510(k) Report

FDA applicant

Collagen Matrix, Inc.

Oakland, NJ47 decisions2001–202516 recalls

FDA records 47 decisions for Collagen Matrix, Inc. (Oakland, NJ) from 2001 to 2025: 47 510(k) clearances. Most are in product codes NPL (Barrier, Animal Source, Intraoral) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 164 for FDA’s reviews in the same codes and years. Its devices cite 85 predicates, 39 of them its own earlier devices. 16 recalls are 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 Collagen Matrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22008: 12009: 22010: 22011: 12012: 12014: 42015: 22016: 12017: 42019: 12020: 12021: 12022: 22023: 12024: 42025: 1
2007high 4 (2014) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2022

2013: 12015: 22018: 22019: 72021: 22022: 2
2007high 7 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Collagen Matrix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NPLBarrier, Animal Source, Intraoral10decisions
  • KGNWound Dressing With Animal-Derived Material (S)8decisions
  • NPMBone Grafting Material, Animal Source7decisions
  • MQVFiller, Bone Void, Calcium Compound7decisions
  • GXQDura Substitute5decisions
  • JXICuff, Nerve4decisions

Also: LYC (3), OLC (1), FTM (1), HRS (1).

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 188 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 164 days; 6 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 85 predicates; 39 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 69 times; 39 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.

  • K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 20059cite it
  • K030921Collagen Topical Wound DressingCollagen Matrix, Inc. · 20037cite it
  • K011695Collagen Dental MembraneCollagen Matrix, Inc. · 20015cite it
  • K012814Collagen Nerve CuffCollagen Matrix, Inc. · 20014cite it
  • K062881Collagen Dental Menbrane - Conformable IICollagen Matrix, Inc. · 20064cite it
  • K060952Collagen Nerve WrapCollagen Matrix, Inc. · 20064cite it

What has FDA decided for it lately?

  • K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025
  • K243071Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc. · 2024
  • K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024
  • K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc. · 2024
  • K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc. · 2024
  • K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc. · 2023
  • K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2022
  • K213341Fibrillar Collagen Wound DressingCollagen Matrix, Inc. · 2022

All 47 as Collagen Matrix, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K152600Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed…Aug 3, 2022Class II
  • K043034NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial…Feb 2, 2022Class II
  • K061487RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair…Dec 13, 2021Class II
  • K061487DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)…Dec 13, 2021Class II
  • K100156GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage…Nov 5, 2019Class II
  • K100156GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product…Nov 5, 2019Class II

Other applicant names beginning “Collagen”

FDA records each applicant name separately; these may or may not be the same firm.

Collagen Corp. 10Collagen Solutions, LLC 1