Cas Medical Systems, Inc.
Branford, CT, US
Cas Medical Systems, Inc. appears in FDA device records in Branford, CT. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 13 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Cas Medical Systems, Inc. between 1985 and 2019. The busiest year on record is 1998, with 4. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1998 | 4 |
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | MUD | Substantially Equivalent | |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | MUD | Substantially Equivalent | |
| K150620 | 740 SELECT | MWI | Substantially Equivalent | |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | MUD | Substantially Equivalent | |
| K140430 | 740 SELECT | MWI | Substantially Equivalent | |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | MUD | Substantially Equivalent | |
| K130411 | 740 SELECT | MWI | Substantially Equivalent | |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | MUD | Substantially Equivalent | |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | MUD | Substantially Equivalent | |
| K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | MUD | Substantially Equivalent | |
| K091452 | FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) | MUD | Substantially Equivalent | |
| K083892 | FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) | DQA | Substantially Equivalent | |
| K073036 | FORE-SIGHT, MC-2000 SERIES | DQA | Substantially Equivalent | |
| K063087 | MODIFICATION TO MODEL 750 SERIES MONITOR | MWI | Substantially Equivalent | |
| K061960 | FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 | MUD | Substantially Equivalent | |
| K051257 | ADULT CEREBRAL OXIMETER, MODEL 2040 | DQA | Substantially Equivalent | |
| K051896 | MODEL 750E SERIES MONITOR | MWI | Substantially Equivalent | |
| K050844 | 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL | DQA | Substantially Equivalent | |
| K033048 | CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS | MHX | Substantially Equivalent | |
| K000512 | OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 | DXQ | Substantially Equivalent | |
| K982776 | 9303 NEONATAL/ADULT VITAL SIGNS MONITOR | DQA | Substantially Equivalent | |
| K982135 | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 | DXN | Substantially Equivalent | |
| K980879 | OSCILLOMATE NIBP / SP02 EMS MONITOR | DQA | Substantially Equivalent | |
| K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | DXW | Substantially Equivalent | |
| K926030 | KLEAR-TEMP | FMT | Substantially Equivalent | |
| K925402 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300 | DXN | Substantially Equivalent | |
| K911722 | OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630 | DXN | Substantially Equivalent | |
| K860488 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 | DXN | Substantially Equivalent | |
| K861364 | NEOGUARD ECG ELECTRODES | DXN | Substantially Equivalent | |
| K860196 | OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 | DXN | Substantially Equivalent | |
| K853965 | NEOGUARD CHEST PERCUSSOR | BYI | Substantially Equivalent | |
| K853794 | NEOGUARD REFLECTOR | FMT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DXQBlood Pressure Cuff
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- MUDOximeter, Tissue Saturation
- BYIPercussor, Powered-Electric
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DXWSystem, Phonocatheter, Intracavitary
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0471-2009 | CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0470-2009 | CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private labeled for Transmed in Germany. Model: T2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0469-2009 | CASMED 500cc Unifusor with a short tube. Private labeled for King Systems. Model: P500BAG. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0468-2009 | CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0467-2009 | CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0466-2009 | CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA. The letter A refers to a special quantity designator for a particular customer. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0465-2009 | CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0464-2009 | Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0463-2009 | CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0462-2009 | CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model: 803FGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-0461-2009 | CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. | Terminated | ||
| Z-2203-2008 | 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals. | Software: Audible alarm may be silenced if changed from the factory setting | Terminated | ||
| Z-1023-04 | Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 | Device may not alarm for %SpO2 value limit violations if a specific feature is enabled | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain