Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Global Medical Products, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
364 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962821 | EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHE | Global Medical Products, Ltd. | 1996-11-13 | 117 | 0 |
| K961444 | GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GM | Global Medical Products, Ltd. | 1996-08-01 | 108 | 0 |
| K951448 | GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEED | Global Medical Products, Ltd. | 1996-03-27 | 364 | 0 |
| K951421 | GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MEN | Global Medical Products, Ltd. | 1995-11-16 | 233 | 0 |
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WIT | Global Medical Products, Ltd. | 1995-05-26 | 130 | 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