510(k) Report

FDA applicant

Bio-Med USA, Inc.

Paterson, NJ11 decisions2008–20220 recalls

FDA records 11 decisions for Bio-Med USA, Inc. (Paterson, NJ) from 2008 to 2022: 11 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bio-Med USA”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2022

2008: 12011: 12012: 12013: 12014: 22015: 12017: 12018: 12021: 12022: 1
2008high 2 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Bio-Med USA, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio-Med USA, 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?

  • GEXPowered Laser Surgical Instrument6decisions
  • FMFSyringe, Piston2decisions
  • LBIUnit, Neonatal Phototherapy1decision
  • ODRElectrosurgical Patient Return Electrode1decision
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K133774AtovenBio-Med USA, Inc. · 20141cites it
  • K123710Unitox Botox SyringeBio-Med USA, Inc. · 20131cites it
  • K111831MX-7000 MicroxelBio-Med USA, Inc. · 20111cites it

What has FDA decided for it lately?

  • K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc. · 2022
  • K212082PicoreBio-Med USA, Inc. · 2021
  • K182270Cellene CO2 Laser SystemBio-Med USA, Inc. · 2018
  • K163638Dental 5 Multi Diode laserBio-Med USA, Inc. · 2017
  • K142332BT-400Bio-Med USA · 2015
  • K140837Lucid LYBio-Med USA, Inc. · 2014
  • K133774AtovenBio-Med USA, Inc. · 2014
  • K123710Unitox Botox SyringeBio-Med USA, Inc. · 2013

All 10 as Bio-Med USA, Inc. →The one decision as Bio-Med USA →