Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gainor Medical Europe, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
173 daysmedian FDA review time
445 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | Gainor Medical Europe, Ltd. | 1994-05-02 | 495 | 0 |
| K931828 | CARELET SAFETY LANCET | Gainor Medical Europe, Ltd. | 1993-10-15 | 190 | 0 |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Gainor Medical Europe, Ltd. | 1993-09-13 | 158 | 0 |
| K922441 | SURESEAL BANDAGE | Gainor Medical Europe, Ltd. | 1993-08-10 | 445 | 0 |
| K913333 | I.V. PRIMING SET | Gainor Medical Europe, Ltd. | 1991-10-23 | 89 | 0 |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | Gainor Medical Europe, Ltd. | 1991-06-06 | 371 | 0 |
| K902420 | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | 1991-04-17 | 321 | 0 |
| K902564 | NEEDLE, DIALYSIS | Gainor Medical Europe, Ltd. | 1991-03-01 | 263 | 0 |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Gainor Medical Europe, Ltd. | 1990-11-20 | 173 | 0 |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Gainor Medical Europe, Ltd. | 1990-11-20 | 173 | 0 |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Gainor Medical Europe, Ltd. | 1990-08-01 | 62 | 0 |
| K902417 | BAG, URINE | Gainor Medical Europe, Ltd. | 1990-07-16 | 46 | 0 |
| K900306 | HEMODIALYSIS BLOOD LINES | Gainor Medical Europe, Ltd. | 1990-04-20 | 89 | 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