510(k) Report

FDA applicant

Bio-Med Devices, Inc.

Madison, CT14 decisions1980–20220 recalls

FDA records 14 decisions for Bio-Med Devices, Inc. (Madison, CT) from 1980 to 2022: 14 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and CAP (Monitor, Airway Pressure (Includes Gauge…). Its devices cite 2 predicates, 1 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, anesthesiology panel, where it files most

How often FDA has decided Bio-Med Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Med Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use9decisions
  • CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2decisions
  • BSKCuff, Tracheal Tube, Inflatable1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K896380IC-2A Mri Adult/Pediatric VentilatorBio-Med Devices, Inc. · 19902cite it
  • K896381MVP-10 Mri Infant VentilatorBio-Med Devices, Inc. · 19902cite it
  • K942938Crossvent-4 VentilatorBio-Med Devices, Inc. · 19952cite it

What has FDA decided for it lately?

  • K213948OxyMinderBio-Med Devices, Inc. · 2022
  • K173973TV-100Bio-Med Devices, Inc. · 2018
  • K942938Crossvent-4 VentilatorBio-Med Devices, Inc. · 1995
  • K896380IC-2A Mri Adult/Pediatric VentilatorBio-Med Devices, Inc. · 1990
  • K896381MVP-10 Mri Infant VentilatorBio-Med Devices, Inc. · 1990
  • K873614CBG Cuff ManometerBio-Med Devices, Inc. · 1988
  • K871336M-1 Pressure MonitorBio-Med Devices, Inc. · 1987
  • K871337M-2 Oxygen/Temperature MonitorBio-Med Devices, Inc. · 1987

All 14 as Bio-Med Devices, Inc. →