Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZW — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
187 daysmedian FDA review time
367 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017-02-27 | 69 | 0 |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | Excelsior Medical Corporation | 2014-11-14 | 367 | 1 |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 5045 | App Pharmaceuticals, LLC | 2010-06-18 | 267 | 1 |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; | Medefil, Inc. | 2010-02-03 | 174 | 4 |
| K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK F | Becton, Dickinson & CO | 2009-06-10 | 86 | 0 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Excelsior Medical Corp. | 2007-02-23 | 268 | 13 |
| K023740 | SYREX PRE-FILLED SYRINGE | Excelsior Medical Corp. | 2003-05-13 | 187 | 1 |
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