510(k) Report

FDA applicant

Ivy Biomedical Systems, Inc.

Branford, CT27 decisions1986–20240 recalls

FDA records 27 decisions for Ivy Biomedical Systems, Inc. (Branford, CT) from 1986 to 2024: 27 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and DPS (Electrocardiograph). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ivy Biomedical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 32011: 12016: 12017: 12018: 12020: 12021: 22024: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ivy Biomedical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ivy Biomedical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)10decisions
  • DPSElectrocardiograph4decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging3decisions
  • DQAOximeter3decisions
  • GWMDevice, Monitoring, Intracranial Pressure1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

Also: DSK (1), DRS (1), DSA (1), MHX (1), CCK (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 212 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 19983cite it
  • K023616Physiological Monitor, Model 3000 (Series)Ivy Biomedical Systems, Inc. · 20021cites it
  • K882118Model 700 Patient MonitorIvy Biomedical Systems, Inc. · 19881cites it

What has FDA decided for it lately?

  • K240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc. · 2024
  • K202138Cardiac Trigger MonitorIvy Biomedical Systems, Inc. · 2021
  • K203653MRI PPG Patient CableIvy Biomedical Systems, Inc. · 2021
  • K192852MRI ECG Patient CableIvy Biomedical Systems, Inc. · 2020
  • K171778MR Wireless Gating System, Model WGS-100Ivy Biomedical Systems, Inc. · 2018
  • K170828Cardiac Trigger MonitorIvy Biomedical Systems, Inc. · 2017
  • K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorIvy Biomedical Systems, Inc. · 2016
  • K110987Cardiac Trigger MonitorIvy Biomedical Systems, Inc. · 2011

All 27 as Ivy Biomedical Systems, Inc. →