Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exelint International, Co. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
433 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle | Exelint International, Co. | 2025-12-12 | 246 | 0 |
| K152183 | EXELINT SecureTouch Safety Hypodermic Needle | Exelint International, Co. | 2015-11-02 | 89 | 0 |
| K101309 | EXELINT ALUMINUM HUB BLUNT NEEDLES | Exelint International, Co. | 2010-10-20 | 163 | 0 |
| K020189 | EXEL BUTTERFLY SCALP VEIN SET | Exelint International, Co. | 2003-03-27 | 433 | 0 |
| K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET | Exelint International, Co. | 2001-05-14 | 112 | 0 |
| K003627 | EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET | Exelint International, Co. | 2001-02-08 | 76 | 0 |
| K001496 | A.V. FISTULA NEEDLE | Exelint International, Co. | 2000-08-01 | 78 | 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