Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Cyanamid Co. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
295 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930992 | FLEXON AND STAINLESS STEEL SUTURES | American Cyanamid Co. | 1993-12-17 | 295 | 0 |
| K931056 | DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING | American Cyanamid Co. | 1993-07-08 | 129 | 0 |
| K921696 | CUTTING AND COAGULATION DEVICES AND ACCESSORIES | American Cyanamid Co. | 1992-11-18 | 224 | 0 |
| K922348 | VALTRAC(R) INTRODUCER FORCEP | American Cyanamid Co. | 1992-06-09 | 21 | 0 |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | American Cyanamid Co. | 1990-07-05 | 170 | 0 |
| K896946 | COATED NOVAFIL, POLYBUTESTER, MESH | American Cyanamid Co. | 1990-05-07 | 145 | 0 |
| K823552 | APPOSE SKIN STAPLER & REMOVER | American Cyanamid Co. | 1983-06-15 | 197 | 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