Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Consumer Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
555 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOU | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 | 53 | 0 |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | 1996-01-17 | 555 | 0 |
| K954007 | PARALLEL | Johnson & Johnson Consumer Products, Inc. | 1995-11-22 | 89 | 0 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 | 16 | 0 |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | 175 | 0 |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | 238 | 0 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 | 83 | 0 |
| K840679 | SERENITY CONTOURED ABSORBENT SHIELDS | Johnson & Johnson Consumer Products, Inc. | 1984-03-22 | 36 | 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