Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Safety Syringes Co., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
362 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET | U.S. Safety Syringes Co., Inc. | 2009-03-10 | 13 | 0 |
| K090122 | NUOVOGUARD | U.S. Safety Syringes Co., Inc. | 2009-02-05 | 15 | 0 |
| K083454 | NUOVOCATH | U.S. Safety Syringes Co., Inc. | 2008-12-04 | 13 | 0 |
| K080665 | NOVOLET | U.S. Safety Syringes Co., Inc. | 2008-05-13 | 64 | 0 |
| K080660 | IV ADMINISTRATION SET | U.S. Safety Syringes Co., Inc. | 2008-05-13 | 64 | 0 |
| K003381 | SHIELDING NEEDLE HOLDER | U.S. Safety Syringes Co., Inc. | 2001-04-23 | 174 | 0 |
| K990831 | SUPERGUARD SAFETY SYRINGE | U.S. Safety Syringes Co., Inc. | 2000-03-08 | 362 | 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