510(k) Report

FDA applicant

Tei Biosciences, Inc.

Boston, MA16 decisions2002–201716 recalls

FDA records 16 decisions for Tei Biosciences, Inc. (Boston, MA) from 2002 to 2017: 16 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 30 predicates, 18 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2017

2007: 12008: 12009: 12010: 12013: 12016: 12017: 1
2007high 1 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

15in 2023

2017: 12023: 15
2007high 15 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Tei Biosciences, 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?

  • FTMMesh, Surgical7decisions
  • KGNWound Dressing With Animal-Derived Material (S)5decisions
  • FTLMesh, Surgical, Polymeric2decisions
  • PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse…1decision
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 30 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 18 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.

  • K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 20025cite it
  • K083898SurgimendTei Biosciences, Inc. · 20094cite it
  • K023778DressskinTei Biosciences, Inc. · 20034cite it
  • K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 20084cite it
  • K051766OrthomendTei Biosciences, Inc. · 20053cite it
  • K031188OrthomendTei Biosciences, Inc. · 20032cite it

What has FDA decided for it lately?

  • K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc. · 20171 recall
  • K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 20164 recalls
  • K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013
  • K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 20103 recalls
  • K083898SurgimendTei Biosciences, Inc. · 20093 recalls
  • K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
  • K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 20074 recalls
  • K061407Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006

All 16 as Tei Biosciences, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K100261PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm…May 23, 2023Class II
  • K100261PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4…May 23, 2023Class II
  • K171357SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm…May 23, 2023Class II
  • K071807Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12…May 23, 2023Class II
  • K083898SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…May 23, 2023Class II
  • K153690PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm…May 23, 2023Class II