510(k) Report

FDA applicant

Purgo Biologics, Inc.

Seongnam-Si, KR6 decisions2018–20240 recalls

FDA records 6 decisions for Purgo Biologics, Inc. (Seongnam-Si, KR) from 2018 to 2024: 6 510(k) clearances. Most are in product codes NPM (Bone Grafting Material, Animal Source) and NPL (Barrier, Animal Source, Intraoral). Since 2016 its 510(k)s took a median of 359 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 7 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, dental panel, where it files most

How often FDA has decided Purgo Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 12020: 12023: 22024: 1
2018high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Purgo Biologics, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NPMBone Grafting Material, Animal Source3decisions
  • NPLBarrier, Animal Source, Intraoral1decision
  • NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1decision
  • NPKBarrier, Synthetic, Intraoral1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 359 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 221 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc. · 20181cites it

What has FDA decided for it lately?

  • K230305THE Graft CollagenPurgo Biologics, Inc. · 2024
  • K230091THE CoverPurgo Biologics, Inc. · 2023
  • K222549OpenTexPurgo Biologics, Inc. · 2023
  • K191737The Graft Bone SubstitutePurgo Biologics, Inc. · 2020
  • K180992BiotexPurgo Biologics, Inc. · 2019
  • K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc. · 2018

All 6 as Purgo Biologics, Inc. →