Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Medical Products, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
472 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931417 | STERILE EQUIPMENT COVERS | Custom Medical Products, Ltd. | 1995-07-06 | 836 | 0 |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | Custom Medical Products, Ltd. | 1994-07-08 | 472 | 0 |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | Custom Medical Products, Ltd. | 1994-05-05 | 442 | 0 |
| K931418 | SURGICAL DRAPE | Custom Medical Products, Ltd. | 1994-05-05 | 409 | 0 |
| K931455 | HEAD SHEET | Custom Medical Products, Ltd. | 1994-05-05 | 408 | 0 |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Custom Medical Products, Ltd. | 1994-01-25 | 287 | 0 |
| K926519 | SURGICAL GOWN | Custom Medical Products, Ltd. | 1993-08-12 | 225 | 0 |
| K900847 | ENEMA KIT 'Y' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 | 50 | 0 |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 | 50 | 0 |
| K895084 | APERTURE | Custom Medical Products, Ltd. | 1989-10-27 | 74 | 0 |
| K893681 | MAMM-AIRE CP | Custom Medical Products, Ltd. | 1989-07-20 | 65 | 0 |
| K880905 | MAMMOGRAPHY MOVING GRID BUCKY | Custom Medical Products, Ltd. | 1988-03-21 | 19 | 0 |
| K834076 | ARTHROSCOPIC LEG HOLDER 434-21 | Custom Medical Products, Ltd. | 1983-12-27 | 32 | 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