Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Univec, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

93 daysmedian FDA review time

1007 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K020500	UNIVEC BIFURCATED SLIDING SHEATH SYRINGE	Univec, Inc.	2002-03-19	33
K993996	UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE	Univec, Inc.	2000-07-17	236
K000747	UNIVEC TWO PIECE SYRINGE	Univec, Inc.	2000-06-08	93
K961877	PISTON SYRINGE	Univec, Inc.	1996-08-07	89
K933469	UNIVEC NON-REUSABLE SYRINGE	Univec, Inc.	1996-04-18	1007
K951619	UNIVEC NONREUSABLE LOCKING SYRINGE	Univec, Inc.	1995-06-06	71
K943679	UNIVEC NONRESUSABLE LOCKING SYRINGE	Univec, Inc.	1994-12-12	139

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