Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Look, Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
381 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943949 | POLYVIOLENE SURGICL SUTURE | Look, Inc. | 1994-11-10 | 100 | 0 |
| K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE | Look, Inc. | 1993-12-23 | 147 | 0 |
| K926586 | REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES | Look, Inc. | 1993-12-22 | 386 | 0 |
| K926167 | POLYVIOLENE SUTURE-REVISED LABELING | Look, Inc. | 1993-12-17 | 381 | 0 |
| K926168 | SILK SUTURES-REVISED LABELING | Look, Inc. | 1993-12-17 | 381 | 0 |
| K926588 | REVISED LABELING FOR POLYPROPYLENE SUTURE | Look, Inc. | 1993-12-17 | 381 | 0 |
| K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) | Look, Inc. | 1993-12-17 | 381 | 0 |
| K913530 | LOOK VISCODISSECTOR | Look, Inc. | 1991-10-21 | 74 | 0 |
| K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | Look, Inc. | 1990-10-25 | 107 | 1 |
| K903584 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | Look, Inc. | 1990-10-11 | 64 | 0 |
| K904054 | POLYVIOLENE(TM) SUTURE | Look, Inc. | 1990-10-03 | 64 | 0 |
| K903624 | PLAIN AND CHROMIC GUT SUTURE | Look, Inc. | 1990-09-18 | 41 | 0 |
| K896554 | GUT SUTURES | Look, Inc. | 1990-05-31 | 195 | 0 |
| K897190 | LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | Look, Inc. | 1990-03-28 | 90 | 0 |
| K882536 | OPHTHALMIC PAO VALVE | Look, Inc. | 1988-09-09 | 80 | 0 |
| K872945 | LOOK FLUID DISTRIBUTION SET | Look, Inc. | 1987-10-22 | 86 | 0 |
| K872944 | LOOK SPRING-ASSIST SYRINGES | Look, Inc. | 1987-09-04 | 38 | 0 |
| K872884 | LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH | Look, Inc. | 1987-08-10 | 19 | 0 |
| K870902 | LOOK RETROBULBAR NEEDLES | Look, Inc. | 1987-03-20 | 15 | 0 |
| K870438 | LOOK IRRIGATING CANNULAS | Look, Inc. | 1987-02-20 | 17 | 0 |
| K870439 | LOOK IRRIGATING CYSTOTOMES | Look, Inc. | 1987-02-20 | 17 | 0 |
| K870440 | LOOK LENS LOOPS | Look, Inc. | 1987-02-20 | 17 | 0 |
| K870436 | LOOK IRRIGATING/ASPIRATING CANNULAS | Look, Inc. | 1987-02-20 | 17 | 0 |
| K870437 | LOOK CAPSULE POLISHERS/SCRAPERS | Look, Inc. | 1987-02-20 | 17 | 0 |
| K870441 | LOOK CORTEX EXTRACTORS | Look, Inc. | 1987-02-20 | 17 | 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