Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excelsior Medical Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
187 daysmedian FDA review time
280 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130975 | SWABCAP AND SWABFLUSH | Excelsior Medical Corp. | 2013-12-24 | 260 | 2 |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | Excelsior Medical Corp. | 2011-02-10 | 280 | 0 |
| K083508 | SWABCAP | Excelsior Medical Corp. | 2009-04-28 | 153 | 0 |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | Excelsior Medical Corp. | 2008-12-18 | 83 | 0 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Excelsior Medical Corp. | 2007-02-23 | 268 | 13 |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | Excelsior Medical Corp. | 2005-12-09 | 32 | 1 |
| K023740 | SYREX PRE-FILLED SYRINGE | Excelsior Medical Corp. | 2003-05-13 | 187 | 1 |
| K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHL | Excelsior Medical Corp. | 1996-10-25 | 88 | 1 |
| K942349 | MICROBORE EXTENSION SET | Excelsior Medical Corp. | 1995-02-08 | 267 | 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