510(k) Report

FDA applicant

Filligent Limited

Austin, TX2 decisions2011–20130 recalls

FDA records 2 decisions for Filligent Limited (Austin, TX) from 2011 to 2013: 2 510(k) clearances. Most are in product codes OUK (Surgical Mask With Antimicrobial/Antiviral Agent) and ONT (N95 Respirator With Antimicrobial/Antiviral…). Its devices cite 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Filligent Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12013: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Filligent Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OUKSurgical Mask With Antimicrobial/Antiviral Agent1decision
  • ONTN95 Respirator With Antimicrobial/Antiviral Agent1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013Filligent Limited · 20113cite it
  • K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 20131cites it

What has FDA decided for it lately?

  • K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013
  • K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013Filligent Limited · 2011

All 2 as Filligent Limited →