Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Patient Care, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895431 | JOHNSON & JOHNSON TUBE SECUREMENT DEVICE | Johnson & Johnson Patient Care, Inc. | 1989-10-13 | 37 | 0 |
| K892851 | ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER | Johnson & Johnson Patient Care, Inc. | 1989-09-26 | 161 | 0 |
| K890545 | NU-DERM HYDROCOLLOID DRESSING | Johnson & Johnson Patient Care, Inc. | 1989-03-23 | 48 | 0 |
| K884749 | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE | Johnson & Johnson Patient Care, Inc. | 1988-12-15 | 31 | 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