Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcare Custom Packaging, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
420 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | 1996-01-19 | 87 | 0 |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | 1995-12-21 | 87 | 0 |
| K952759 | TOWEL PACK | Medcare Custom Packaging, Inc. | 1995-09-29 | 105 | 0 |
| K950390 | URETHRAL CATHETERIZATION TRAY | Medcare Custom Packaging, Inc. | 1995-05-30 | 118 | 0 |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | 1995-04-10 | 256 | 0 |
| K951149 | SINGLE USE INSTRUMENT TRAY | Medcare Custom Packaging, Inc. | 1995-04-06 | 24 | 0 |
| K934732 | PELVIC EXAM TRAY | Medcare Custom Packaging, Inc. | 1994-12-30 | 457 | 0 |
| K942000 | BURN DRESSING TRAY | Medcare Custom Packaging, Inc. | 1994-05-20 | 25 | 0 |
| K936261 | CATHETER INSERTION TRAY | Medcare Custom Packaging, Inc. | 1994-03-10 | 80 | 0 |
| K922179 | CATHETER INSERTION TRAY | Medcare Custom Packaging, Inc. | 1993-07-02 | 420 | 0 |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Medcare Custom Packaging, Inc. | 1990-08-01 | 99 | 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