Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tei Biosciences, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
316 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Tei Biosciences, Inc. | 2017-02-16 | 115 | 1 |
| K153690 | PriMatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2016-02-22 | 61 | 3 |
| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Tei Biosciences, Inc. | 2013-08-05 | 91 | 0 |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | Tei Biosciences, Inc. | 2010-12-10 | 316 | 3 |
| K083898 | SURGIMEND | Tei Biosciences, Inc. | 2009-02-04 | 37 | 3 |
| K083440 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Tei Biosciences, Inc. | 2008-12-12 | 22 | 0 |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | Tei Biosciences, Inc. | 2007-08-06 | 35 | 4 |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Tei Biosciences, Inc. | 2006-06-29 | 38 | 0 |
| K060829 | COSMATRIX | Tei Biosciences, Inc. | 2006-05-17 | 51 | 0 |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | 2006-05-17 | 37 | 0 |
| K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | 2006-05-15 | 35 | 1 |
| K051766 | ORTHOMEND | Tei Biosciences, Inc. | 2005-08-11 | 42 | 0 |
| K051190 | XENFORM SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | 2005-06-10 | 31 | 0 |
| K023778 | DRESSSKIN | Tei Biosciences, Inc. | 2003-09-29 | 321 | 0 |
| K031188 | ORTHOMEND | Tei Biosciences, Inc. | 2003-06-27 | 73 | 0 |
| K020455 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | 2002-04-03 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda