Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tissue Technologies, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
167 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL M | Tissue Technologies, Inc. | 2000-07-24 | 17 | 0 |
| K000849 | SOFTFORM FACIAL IMPLANT | Tissue Technologies, Inc. | 2000-05-19 | 65 | 0 |
| K982475 | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL | Tissue Technologies, Inc. | 1998-09-22 | 68 | 0 |
| K973462 | SOFTFORM FACIAL IMPLANT | Tissue Technologies, Inc. | 1997-11-24 | 73 | 0 |
| K970804 | TRU-PULSE CO2 SURGICAL LASER | Tissue Technologies, Inc. | 1997-06-03 | 91 | 0 |
| K963683 | TRU-PULSE LASER (MODIFIED) | Tissue Technologies, Inc. | 1997-02-12 | 167 | 0 |
| K962496 | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) | Tissue Technologies, Inc. | 1996-09-03 | 69 | 0 |
| K960481 | SOFT TISSUE AUGMENTATION TUBE | Tissue Technologies, Inc. | 1996-04-01 | 59 | 0 |
| K952049 | TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM | Tissue Technologies, Inc. | 1995-07-21 | 81 | 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