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

Care Fusion — Predicate Candidate Screening

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

174 daysmedian FDA review time

346 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233021	BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vi	Care Fusion	2024-03-06	166	0
K231888	BD Texium™ Needle-Free Syringe	Care Fusion	2023-09-25	90	0
K221319	BD Alaris™ Pump Epidural Infusion Set	Care Fusion	2023-07-21	441	0
K221327	BD Alaris™ Pump Infusion Sets	Care Fusion	2023-07-21	441	0
K223101	BD Secondary Infusion Set	Care Fusion	2023-05-12	224	0
K223088	BD SmartSite™ Needle-Free Connector	Care Fusion	2023-04-07	189	0
K223076	BD Texium™ Closed Male Luer	Care Fusion	2023-03-24	175	0
K201155	PleurX Peritoneal Catheter System	Care Fusion	2020-10-21	174	0
K170405	BD Curve Ascites Shunt	Care Fusion	2017-11-02	265	0
K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Ha	Care Fusion	2017-09-11	109	0
K153748	AirLife Misty Finity Nebulizer	Care Fusion	2017-05-17	505	0
K160437	PleurX Peritoneal Catheter System	Care Fusion	2016-11-03	260	0
K160450	Pleurx Pleural Catheter System	Care Fusion	2016-10-31	256	0
K151303	AirLife Infant Heated Wire Circuit	Care Fusion	2016-01-21	248	2
K151125	AVAflex Vertebral Balloon System	Care Fusion	2015-11-24	210	0
K150523	AVAmax Vertebral Balloon	Care Fusion	2015-10-29	241	0
K141965	PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT	Care Fusion	2015-07-02	346	0
K141722	CAREFUSION GOLD TISSUE MARKER	Care Fusion	2015-01-23	212	0
K143234	MaxZero Administration Sets	Care Fusion	2014-11-20	10	0
K141552	ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS	Care Fusion	2014-09-05	86	0
K140831	MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR	Care Fusion	2014-04-15	13	0
K131820	AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOO	Care Fusion	2013-10-04	106	0
K131824	AVAFLEX VERTEBRAL BALLOON SYSTEM	Care Fusion	2013-10-03	105	0
K132413	MZ1000	Care Fusion	2013-08-29	27	0
K123527	AIRLIFE	Care Fusion	2013-04-25	160	0
K122422	PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PL	Care Fusion	2012-10-24	76	0
K121849	PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT,	Care Fusion	2012-10-18	115	0
K120518	END TIDAL CO2 NASAL CANNULA	Care Fusion	2012-05-04	73	0
K113854	PLEURX PERITONEAL CATHETER SYSTEM	Care Fusion	2012-03-19	81	0
K112831	PLEURX PLEURAL CATHETER SYSTEMS	Care Fusion	2012-02-16	141	0
K103211	AVEA VENTILATOR	Care Fusion	2011-05-12	192	15
K101643	MODEL LTV 1100 VENTILATOR	Care Fusion	2011-01-26	230	0
K103064	AVAMAX VERTEBRAL BALLOON	Care Fusion	2011-01-10	84	0
K093463	AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020	Care Fusion	2010-02-26	112	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