Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KGS — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
335 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030031 | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | 2003-01-28 | 25 | 0 |
| K020480 | RBM | Smith & Nephew, Inc. | 2002-03-12 | 27 | 1 |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | 1997-02-25 | 77 | 0 |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | 1995-06-30 | 449 | 0 |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | 1993-11-09 | 273 | 0 |
| K904435 | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | 1991-08-29 | 335 | 0 |
| K911225 | TRAY DOUGH | The Hygenic Corp. | 1991-04-17 | 27 | 0 |
| K904136 | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | 1990-10-02 | 26 | 0 |
| K902001 | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | 1990-05-09 | 7 | 0 |
| K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | 1989-11-20 | 19 | 0 |
| K893995 | DERMACARE TIE HOLDER | Dermacare | 1989-08-11 | 67 | 0 |
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | 1989-02-27 | 118 | 0 |
| K883299 | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 | 19 | 0 |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | 1987-09-16 | 72 | 0 |
| K863570 | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | 1986-09-29 | 17 | 0 |
| K832138 | BIOMER * PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | 1984-05-23 | 327 | 0 |
| K813581 | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | 1982-03-23 | 85 | 0 |
| K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | ETHICON, Inc. | 1981-11-20 | 44 | 0 |
| K792004 | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | 1979-11-05 | 33 | 0 |
| K771554 | SUTURE RETENTION CLAMP | Concept, Inc. | 1977-09-02 | 21 | 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