510(k) Report

FDA applicant

Bio-Medical Devices, Inc.

Irvine, CA7 decisions1994–20041 recall

FDA records 7 decisions for Bio-Medical Devices, Inc. (Irvine, CA) from 1994 to 2004: 7 510(k) clearances. Most are in product codes BYY (Tube, Aspirating, Flexible, Connecting) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Bio-Medical Devices, Inc. since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bio-Medical 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?

  • BYYTube, Aspirating, Flexible, Connecting3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • FQHLavage, Jet1decision
  • GBXCatheter, Irrigation1decision
  • FYAGown, Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K040485Maxair Surgical Helmet SystemBio-Medical Devices, Inc. · 20041 recall
  • K981888Smoke-EvacBio-Medical Devices, Inc. · 1998
  • K955151Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBio-Medical Devices, Inc. · 1996
  • K955149Maxi-Flow Suction Handle/the Reel Thing Tubing ReelBio-Medical Devices, Inc. · 1996
  • K955150Maxi-FlowBio-Medical Devices, Inc. · 1996
  • K940156The Reel ThingBio-Medical Devices, Inc. · 1994
  • K933742Top GunBio-Medical Devices, Inc. · 1994

All 7 as Bio-Medical Devices, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K040485Vitek 2 Reagent Ast-GN73 Test Kit 20 Cards, Catalog 413404Nov 9, 2022Class II