Ivy Biomedical Systems, Inc.
Branford, CT, US
IVY BIOMEDICAL SYSTEMS, INC. appears in FDA device records in Branford, CT. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Ivy Biomedical Systems, Inc. between 1986 and 2024. The busiest year on record is 1988, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2002 | 1 |
| 2009 | 3 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240087 | RT Carbon ECG Leads | DSA | Substantially Equivalent | |
| K202138 | Cardiac Trigger Monitor | DRT | Substantially Equivalent | |
| K203653 | MRI PPG Patient Cable | LNH | Substantially Equivalent | |
| K192852 | MRI ECG Patient Cable | LNH | Substantially Equivalent | |
| K171778 | MR Wireless Gating System, Model WGS-100 | LNH | Substantially Equivalent | |
| K170828 | Cardiac Trigger Monitor | DRT | Substantially Equivalent | |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | DRT | Substantially Equivalent | |
| K110987 | CARDIAC TRIGGER MONITOR | DRT | Substantially Equivalent | |
| K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | DQA | Substantially Equivalent | |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | DRT | Substantially Equivalent | |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | DRT | Substantially Equivalent | |
| K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | DRT | Substantially Equivalent | |
| K982255 | MODEL 2000 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K964961 | MODEL 405T WITH ETCO2 OPTION | CCK | Substantially Equivalent | |
| K955546 | PATIENT MONITOR MODEL 405P | DPS | Substantially Equivalent | |
| K945099 | PARAMETERS MONITORES | MHX | Substantially Equivalent | |
| K912139 | MODEL 704 | GWM | Substantially Equivalent | |
| K904606 | MODEL 405 | DPS | Substantially Equivalent | |
| K901504 | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. | DQA | Substantially Equivalent | |
| K884455 | MODEL 702 ECG/RESPIRATION/TEMPERATURE | DRT | Substantially Equivalent | |
| K884096 | PATIENT MONITOR MODEL 701 | DRT | Substantially Equivalent | |
| K884662 | PATIENT MONITOR MODEL 703 | DPS | Substantially Equivalent | |
| K882118 | MODEL 700 PATIENT MONITOR | DRS | Substantially Equivalent | |
| K882188 | MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K880066 | MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR | DRT | Substantially Equivalent | |
| K862647 | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 | DSK | Substantially Equivalent | |
| K854840 | PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A | DPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221108 | 1221108 | IVY BIOMEDICAL SYSTEMS, INC. | 11 BUSINESS PARK DR., Branford, CT 06405 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- OEZCardiovascular Procedure Kit
- DSKComputer, Blood-Pressure
- GWMDevice, Monitoring, Intracranial Pressure
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- IXOSynchronizer, Ecg / Respirator, Radiographic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- LNHSystem, Nuclear Magnetic Resonance Imaging
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain