510(k) Report

FDA applicant

3-D Matrix, Inc.

Newton, MA9 decisions2015–20261 recall

FDA records 9 decisions for 3-D Matrix, Inc. (Newton, MA) from 2015 to 2026: 9 510(k) clearances. Most are in product codes QAU (Hemostatic Device For Endoscopic…) and PHN (Protective Coating, Mucoadhesive Application…). Its devices cite 14 predicates, 4 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 and plastic surgery panel, where it files most

How often FDA has decided 3-D Matrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12019: 12020: 12021: 22022: 12023: 12026 (partial year): 2
2015high 2 (2021) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2015high 1 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — 3-D Matrix, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3-D Matrix, 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?

  • QAUHemostatic Device For Endoscopic Gastrointestinal Use3decisions
  • PHNProtective Coating, Mucoadhesive Application, For The Rectal Mucosa2decisions
  • FRODressing, Wound, Drug2decisions
  • OLROral Wound Dressing1decision
  • NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable1decision

Whose devices does it build on?

Its devices cite 14 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K213552PuraStat-RM3-D Matrix, Inc. · 20222cite it
  • K143058PuraDerm Gel3-D Matrix, Inc. · 20152cite it
  • K222481PuraStat3-D Matrix, Inc. · 20231cites it
  • K210211PuraStat-OM3-D Matrix, Inc. · 20211cites it
  • K210098PuraStat-GI3-D Matrix, Inc. · 20211cites it

What has FDA decided for it lately?

  • K261504PuraStat-RM3-D Matrix, Inc. · 2026
  • K261503PuraStat GI3-D Matrix, Inc. · 2026
  • K222481PuraStat3-D Matrix, Inc. · 2023
  • K213552PuraStat-RM3-D Matrix, Inc. · 2022
  • K210211PuraStat-OM3-D Matrix, Inc. · 2021
  • K210098PuraStat-GI3-D Matrix, Inc. · 2021
  • K193085PuraDERM Gel3-D Matrix, Inc. · 2020
  • K183015PuraSinus3-D Matrix, Inc. · 20191 recall

All 9 as 3-D Matrix, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K183015PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006Dec 2, 2019Class II