Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
R. K. Medical L. L. C. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
73 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961925 | POLYESTER NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-07-29 | 73 | 0 |
| K961931 | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-07-29 | 73 | 0 |
| K961389 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | R. K. Medical L. L. C. | 1996-06-18 | 69 | 0 |
| K960327 | NYLON NOABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | 40 | 0 |
| K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | 40 | 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