Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcare Products · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
126 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | Medcare Products | 1984-04-25 | 41 | 0 |
| K841124 | DIALYSIS TRAY | Medcare Products | 1984-04-20 | 36 | 0 |
| K841123 | DRESSING CHANGE TRAY | Medcare Products | 1984-04-17 | 33 | 0 |
| K831374 | MED CARE PREP RAZOR | Medcare Products | 1983-10-04 | 160 | 0 |
| K831663 | TISSUE FORCEPS | Medcare Products | 1983-09-26 | 126 | 0 |
| K831665 | DISPOSABLE NEEDLE HOLDER | Medcare Products | 1983-09-12 | 112 | 0 |
| K831664 | PLASTIC THUMB FORCEPS | Medcare Products | 1983-09-12 | 112 | 0 |
| K831661 | DISPOSABLE SCISSORS | Medcare Products | 1983-08-25 | 94 | 0 |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Medcare Products | 1983-07-19 | 57 | 0 |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Medcare Products | 1983-03-31 | 99 | 0 |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Medcare Products | 1983-01-14 | 23 | 0 |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Medcare Products | 1983-01-14 | 23 | 0 |
| K823855 | MEDCARE INCISION & DRAINAGE TRAY | Medcare Products | 1983-01-14 | 23 | 0 |
| K822577 | OPERAND SUTURE REMOVAL TRAY | Medcare Products | 1982-10-22 | 58 | 0 |
| K822591 | TISSUE FORCEPS | Medcare Products | 1982-10-13 | 35 | 0 |
| K821618 | DISPOSABLE NEEDLE HOLDERS | Medcare Products | 1982-06-21 | 19 | 0 |
| K821617 | DISPOSABLE HEMOSTATS | Medcare Products | 1982-06-21 | 19 | 0 |
| K821143 | DISPOSABLE THUMB FORCEPS | Medcare Products | 1982-05-21 | 30 | 0 |
| K820170 | MED-CARE EMERGENCY SHEARS | Medcare Products | 1982-02-05 | 15 | 0 |
| K812555 | DISPOSABLE SUTURE REMOVAL SCISSORS | Medcare Products | 1981-11-16 | 69 | 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