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

Exel Intl. — Predicate Candidate Screening

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

143 daysmedian FDA review time

469 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K992290	EXEL INJECTION PLUG WITH CAP	Exel Intl.	2000-02-23	231	0
K963658	EXEL AVF SINGLE NEEDLE	Exel Intl.	1998-05-05	609	0
K963659	EXEL I.V. ADMINISTRATION SET	Exel Intl.	1997-12-16	469	0
K926119	EXEL HUBER INFUSION SET ROTATING WING	Exel Intl.	1993-08-11	251	0
K904685	EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)	Exel Intl.	1990-11-21	48	0
K903945	EXEL A-V FISTULA SET	Exel Intl.	1990-11-20	85	0
K895770	EXEL HUBER INFUSION SET	Exel Intl.	1990-07-19	296	1
K895772	EXEL INDWELLING CATHETER	Exel Intl.	1990-02-16	143	0
K895769	EXEL HUBER NEEDLE	Exel Intl.	1990-02-16	143	1
K895768	EXEL SAFELET CATHETER	Exel Intl.	1990-02-16	143	0
K895771	EXEL SPINAL NEEDLES	Exel Intl.	1990-02-16	143	0
K862492	EXEL THREE-WAY STOPCOCK	Exel Intl.	1986-09-25	86	0
K861449	VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)	Exel Intl.	1986-09-16	152	0
K862491	EXEL BUTTERFLY SCALP VEIN SET	Exel Intl.	1986-08-27	57	0
K861152	EXEL VACUUM BLOOD COLLECTING SYSTEM	Exel Intl.	1986-05-06	41	0
K861153	DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES	Exel Intl.	1986-04-23	28	0
K861151	SUEL BLOOD LANCET	Exel Intl.	1986-04-15	20	0
K861150	EXEL DENTAL NEEDLE	Exel Intl.	1986-04-11	16	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