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

Device Labs, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time

317 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K930632	CHEMOSITE IMPLANTABLE DRUG DELIVERY	Device Labs, Inc.	1993-12-22	317	0
K904417	CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM	Device Labs, Inc.	1990-12-05	69	0
K902135	PERCUTANEOUS INTRODUCER KIT	Device Labs, Inc.	1990-08-01	83	13
K901722	CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM	Device Labs, Inc.	1990-07-03	78	0
K883764	INTRAVASCULAR ADMINISTRATION SET	Device Labs, Inc.	1988-12-19	104	0
K882064	LO-CORE NEEDLE	Device Labs, Inc.	1988-07-08	52	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