Mortara Instrument, Inc.
Milwaukee, WI, US
Mortara Instrument, Inc. appears in FDA device records in Milwaukee, WI. FDA records list 51 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 18 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mortara Instrument, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- WELCH ALLYN, INC/MORTARAenforcement report, recall
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Mortara Instrument, Inc. between 1983 and 2019. The busiest year on record is 1992, with 5. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 4 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182297 | Surveyor S2 | DRG | Substantially Equivalent | |
| K173765 | Surveyor Patient Monitor | MHX | Substantially Equivalent | |
| K161517 | Mortara Surveyor Patient Monitor | MHX | Substantially Equivalent | |
| K161465 | CardioConfirm | DQK | Substantially Equivalent | |
| K160685 | Surveyor S4 Mobile Monitor | MHX | Substantially Equivalent | |
| K152626 | H3+ Holter Recorder | MWJ | Substantially Equivalent | |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | DPS | Substantially Equivalent | |
| K141020 | SURVEYOR S4 MOBILE MONITOR | DRG | Substantially Equivalent | |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | DXN | Substantially Equivalent | |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | MHX | Substantially Equivalent | |
| K142105 | ELI 380 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K131929 | SURVEYOR CENTRAL STATION | MHX | Substantially Equivalent | |
| K123556 | MORTARA SURVEYOR PATIENT MONITOR | MHX | Substantially Equivalent | |
| K122073 | ELI 280 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K120865 | RSCRIBE ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 | DPS | Substantially Equivalent | |
| K101403 | ELI 250 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | DPS | Substantially Equivalent | |
| K100127 | ELI 230 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K093339 | ELI PC ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K092663 | ELI 350 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K082946 | MORTARA ELI 350 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K081800 | T12S TELEMETRY TRANSMITTER | DQA | Substantially Equivalent | |
| K070539 | MORTARA ELI 10 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K062677 | ELI 350 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K060135 | MORTARA SURVEYOR TELEMETRY CENTRAL STATION | MHX | Substantially Equivalent | |
| K050896 | H12+ HOLTER RECORDER | DSH | Substantially Equivalent | |
| K043010 | HOLTER RECORDER H3+ | MWJ | Substantially Equivalent | |
| K031182 | ELI 200+ AUDICOR | DPS | Substantially Equivalent | |
| K022618 | X-SCRIBE II | DPS | Substantially Equivalent | |
| K021373 | H12+HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K004017 | H-SCRIBE | MLO | Substantially Equivalent | |
| K974149 | AMBULATORY X-12 TELEMETRY MODULE | DRG | Substantially Equivalent | |
| K942685 | ECG REVIEW STATION | DXJ | Substantially Equivalent | |
| K933143 | MODEL ELI 300 ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K930558 | MORTARA INSTRUMENT, INC. E-SCRIBE | DPS | Substantially Equivalent | |
| K922927 | MORTARA INSTRUMENT ST CENTRAL STATION | DPS | Substantially Equivalent | |
| K915730 | MORTARA INSTRUMENT ODEL ELI 50I | LOS | Substantially Equivalent | |
| K920627 | MODEL ELI 100 ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K920626 | MODEL ELI 200 ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K920377 | MORTARA INSTRUMENT MODEL ECG PREVU | LOS | Substantially Equivalent | |
| K911097 | PR4 | DSH | Substantially Equivalent | |
| K900720 | MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) | DSI | Substantially Equivalent | |
| K902652 | MORTARA INSTRUMENT MODEL ELI 50 | DRT | Substantially Equivalent | |
| K895232 | MODEL ELI-100/ST ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K880664 | MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) | DSI | Substantially Equivalent | |
| K864580 | MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM) | DPS | Substantially Equivalent | |
| K861851 | SIEMENS-ELEMA (SICARD-P) | DPS | Substantially Equivalent | |
| K861850 | BURDICK DIVISION (E-500) | DPS | Substantially Equivalent | |
| K851702 | MORTARA INSTRUMENT MODEL EL-1 | DSI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DSHRecorder, Magnetic Tape, Medical
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0011-2022 | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D | The devices malfunction under specific operator workflows. | Class II | Open, Classified | |
| Z-1485-2021 | AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Terminated | |
| Z-1484-2021 | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Terminated | |
| Z-1483-2021 | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Terminated | |
| Z-1482-2021 | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Terminated | |
| Z-0553-2021 | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. | The radio within the device can become disassociated with the wireless access point. | Class II | Terminated | |
| Z-1819-2020 | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1818-2020 | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1817-2020 | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1816-2020 | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1815-2020 | S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1814-2020 | X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1813-2020 | T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1812-2020 | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1811-2020 | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1810-2020 | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms. | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | Class II | Terminated | |
| Z-1796-2015 | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. | Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system. | Class II | Terminated | |
| Z-0110-2015 | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. | Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain