Tei Biosciences, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Tei Biosciences, Inc.” (first 2002, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 91 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 61 |
| 2017 | 1 | 115 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tei Biosciences, Inc. took a median 115 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 7 | 7 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 5 | 5 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 1 | 1 |
Review panels
Most recent Tei Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | FTM | 2017-02-16 | 115 |
| K153690 | PriMatrix Dermal Repair Scaffold | KGN | 2016-02-22 | 61 |
| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | 2013-08-05 | 91 |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | FRO | 2010-12-10 | 316 |
| K083898 | SURGIMEND | FTM | 2009-02-04 | 37 |
| K083440 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | 2008-12-12 | 22 |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | FTM | 2007-08-06 | 35 |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | 2006-06-29 | 38 |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | FTM | 2006-05-17 | 37 |
| K060829 | COSMATRIX | FTM | 2006-05-17 | 51 |
6 earlier clearances. See the full list in Caduvo.
Recalls
18 product recalls in 2 recall events; 17 initiated in the last five years. Most recent: 2023-05-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tei Biosciences, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Tei Biosciences, Inc.” (first 2002, latest 2017), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tei Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tei Biosciences, Inc. is 46 days.
Which FDA product codes appear under Tei Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 7); KGN (Wound Dressing With Animal-Derived Material(S), 5); FTL (Mesh, Surgical, Polymeric, 2).
Next steps
- See all 16 Tei Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Tei Biosciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.