Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exelint Intl. Co. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
286 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092172 | EXEL I.V. EXTENSION SET | Exelint Intl. Co. | 2010-01-04 | 167 | 0 |
| K052103 | EXEL SECURE TOUCH II SAFETY SYRINGE | Exelint Intl. Co. | 2005-10-19 | 77 | 0 |
| K031500 | EXCEL PRIMARY SOLUTION SET | Exelint Intl. Co. | 2003-07-25 | 73 | 0 |
| K011754 | EXEL SECURETOUCH PTP SYRINGE | Exelint Intl. Co. | 2003-01-22 | 595 | 0 |
| K020533 | EXEL VACULET BLOOD COLLECTION SET | Exelint Intl. Co. | 2002-12-02 | 286 | 0 |
| K022406 | EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET | Exelint Intl. Co. | 2002-09-30 | 69 | 0 |
| K011757 | EXEL COMFORTPOINT INSULIN PEN NEEDLE | Exelint Intl. Co. | 2002-01-23 | 231 | 0 |
| K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE | Exelint Intl. Co. | 2002-01-17 | 142 | 0 |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Exelint Intl. Co. | 2001-12-07 | 88 | 0 |
| K011405 | EXEL INJECTION PLUG WITH CAP | Exelint Intl. Co. | 2001-09-27 | 142 | 0 |
| K010404 | EXEL I.V. ADMINISTRATION SET | Exelint Intl. Co. | 2001-08-30 | 199 | 0 |
| K992039 | EXEL I.V. BLOOD LINE SET | Exelint Intl. Co. | 2000-02-10 | 238 | 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