Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Resources, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
323 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931250 | PHYNE-TOUCH PF | Medical Resources, Ltd. | 1994-01-28 | 323 | 0 |
| K914628 | PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF | Medical Resources, Ltd. | 1991-11-07 | 86 | 0 |
| K903559 | HIGH RISK | Medical Resources, Ltd. | 1990-12-21 | 135 | 0 |
| K895195 | CHEMO-TOUCH | Medical Resources, Ltd. | 1990-03-15 | 216 | 0 |
| K894212 | PHYNE-TOUCH-STERILE | Medical Resources, Ltd. | 1989-08-29 | 71 | 0 |
| K885096 | PHYNE-VU | Medical Resources, Ltd. | 1989-07-25 | 228 | 0 |
| K890983 | PHYNE-TOUCH (PATIENT EXAMINATION GLOVES) | Medical Resources, Ltd. | 1989-04-28 | 60 | 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