Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J.J. Skinner, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
916 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961227 | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TR | J.J. Skinner, Inc. | 1996-06-10 | 74 | 0 |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | J.J. Skinner, Inc. | 1996-05-10 | 9 | 0 |
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | J.J. Skinner, Inc. | 1995-05-03 | 916 | 0 |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | J.J. Skinner, Inc. | 1994-05-11 | 559 | 0 |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | J.J. Skinner, Inc. | 1994-04-11 | 529 | 0 |
| K903545 | CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS | J.J. Skinner, Inc. | 1990-11-13 | 99 | 0 |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | J.J. Skinner, Inc. | 1990-08-31 | 25 | 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