Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Johnson & Johnson Medical, Div. of Ethicon, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
207 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETE | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1999-08-20 | 207 | 0 |
| K990395 | BARRIER SURGICAL GOWNS | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1999-04-13 | 63 | 0 |
| K983240 | NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-30 | 76 | 0 |
| K983234 | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-25 | 71 | 0 |
| K983394 | MODIFICATION TO TIELLE HYDROPOLMER DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-03 | 39 | 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