Data / Medical devices / United States / Bio-Med Devices, Inc.
Bio-Med Devices, Inc.: FDA-registered device maker in Guilford, CT, United States, 6 510(k) clearances
Bio-Med Devices, Inc. is registered with the FDA (registration 1218704) in Guilford, CT, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 17, 2022. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1218704
- FEI number
- 3003952420
- Address
- 61 Soundview RD, Guilford, CT, United States, 06437
- Owner or operator
- BIO-MED DEVICES, INC. (1218704)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 16, 1999
- Registered through
- 2026
- Brand names listed
- AIR-OXYGEN BLENDER, BIO-MED BREATHING CIRCUIT, BIO-MED DEVICES BREATHING CIRCUIT, CROSSVENT VENTILATOR, CROSSVENT-2i+, CROSSVENT-3+, CROSSVENT-4+, IC-2A VENTILATOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2022 | K213948 | OxyMinder | CCL | Substantially Equivalent | Bio-Med Devices, Inc. | accessdata.fda.gov |
| July 20, 2018 | K173973 | TV-100 | CBK | Substantially Equivalent | Bio-Med Devices, Inc. | accessdata.fda.gov |
| September 19, 1995 | K942938 | CROSSVENT-4 VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | Bio-Med Devices, Inc. | accessdata.fda.gov |
| October 7, 1993 | K925982 | BMD AIR/OXYGEN BLENDER | BZR | Substantially Equivalent | Biomedical Devices, Inc. | accessdata.fda.gov |
| June 5, 1987 | K871336 | M-1 PRESSURE MONITOR | CAP | Substantially Equivalent | Bio-Med Devices, Inc. | accessdata.fda.gov |
| April 21, 1987 | K871139 | M-10 VENTILATION MONITOR | CAP | Substantially Equivalent | Bio-Med Devices, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 19, 2010 | 57051 | Not yet classified | Terminated | Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare v | Breathing circuit may disconnect between the adapter adjacent tubing cuff | accessdata.fda.gov |
| December 6, 2004 | 30580 | Not yet classified | Terminated | Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1- | Adapters may be occluded potentially preventing inhalation | accessdata.fda.gov |
| November 7, 2003 | 27937 | Not yet classified | Terminated | MVP-10 Pediatric/ Neonatal Volume Ventilator | Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- All makers of Ventilator, Continuous, Facility Use
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Analyzer, Gas, Oxygen, Gaseous-Phase
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
Updated March 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.