# Ivy Biomedical Systems, Inc.

- Location (FDA's records): Branford, CT
- FDA decisions: 27 (1986–2024): 27 510(k) clearances
- Product codes: DRT (10), DPS (4), LNH (3), DQA (3), GWM (1), DXN (1), DSK (1), DRS (1), DSA (1), MHX (1), CCK (1)
- 510(k) review time since 2016: median 212 days, against 112 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Vital Connections, Inc.: 1 (https://510kreport.com/company/vital-connections)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)

## Firms that cite its devices most
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Wr Medical Electronics Co.: 2 (https://510kreport.com/company/wr-medical-electronics)
- Novametrix Medical Systems, Inc.: 1 (https://510kreport.com/company/novametrix-medical-systems)

## Its most-cited devices
- K982255: Model 2000 Pulse Oximeter (1998), cited by 3
- K023616: Physiological Monitor, Model 3000 (Series) (2002), cited by 1
- K882118: Model 700 Patient Monitor (1988), cited by 1

## Recent decisions
- K240087: RT Carbon ECG Leads (Sep 13, 2024)
- K202138: Cardiac Trigger Monitor (May 14, 2021)
- K203653: MRI PPG Patient Cable (Mar 2, 2021)
- K192852: MRI ECG Patient Cable (Mar 28, 2020)
- K171778: MR Wireless Gating System, Model WGS-100 (Mar 14, 2018)
- K170828: Cardiac Trigger Monitor (May 17, 2017)
- K151781: Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (May 27, 2016)
- K110987: Cardiac Trigger Monitor (Jul 22, 2011)

Source page: https://510kreport.com/company/ivy-biomedical-systems