510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 2842 of 3529

510(k) clearances, page 2842 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864654	Colin Stbp-780 Stress Test Blood Pressure Monitor	Colin Medical Instruments Corp.	DXN	Class II	1987-02-10
K864349	Mediport II Single Lum/port Implant Vasc Acs Port	C.R. Bard Inc	LJT	Class II	1987-02-10
K864199	Salter Labs #4001 Oral Nasal CO2 Sampling Cannula	Salter Labs	CCK	Class II	1987-02-10
K864166	25 Watt Carbon Dioxide Medical Laser for Neurology	Weck Surgical Systems	LKW	Class III	1987-02-10
K863898	Multilith 3 Models 1350, 3350, 1370, 3370	Ela Medical, Inc.	DXY	Class III	1987-02-10
K863872	Tamper Hamper	Hydro-Med Products, Inc.	LPZ	Unclassified	1987-02-10
K863700	Rt2800(115v)/h4008c and Rt2800(220/240v)/h4008ce	General Electric Co.	ITX	Class II	1987-02-10
K863608	Datascope Balloon Dilatation Catheter	Datascope Corp.			1987-02-10
K863228	Bird 6400St Volume Ventilator	Bird Products Corp.	CBK	Class II	1987-02-10
K862854	Osteo Titanium Dental Implant	Osteo Implant Corp.	DZE	Class II	1987-02-10
K870167	u.v. Sunlamp 95Uf-11	Light Sources, Inc.	FTC	Class II	1987-02-09
K870241	Compress and Bandage, Various Sizes	Fraass Survival Systems, Inc.	FRO	Unclassified	1987-02-06
K870239	Dressing, Burn, 24 by 36 Inches	Fraass Survival Systems, Inc.	NAD	Class I	1987-02-06
K870217	Femoral Cement Removal Instruments	Kenneth J. Hoek, M.D., Inc.	HTW	Class I	1987-02-06
K870213	Modified Profile Femoral Hip	Depuy, Inc.			1987-02-06
K870185	Bandage, Gauze (Nonabsor. Gauze for External Use)	Fraass Survival Systems, Inc.	NAD	Class I	1987-02-06
K870184	Bandage, Gauze, Fine Mesh, 3 by 8 Inches	Fraass Survival Systems, Inc.	FRO	Unclassified	1987-02-06
K870174	Mccutchen Femoral Hip Prosthesis	Dow Corning Wright			1987-02-06
K870152	Allergen Specific Controls	3M Company	DHB	Class II	1987-02-06
K870105	Infant Cast Table	Mizuho Orthopedic Systems Inc			1987-02-06
K870104	Radiolucent Table Extension	Mizuho Orthopedic Systems Inc	FWZ	Class I	1987-02-06
K870101	Clark Socket, Side Rail Socket, Side Rail Section	Mizuho Orthopedic Systems Inc	FWZ	Class I	1987-02-06
K870099	Pivoting Surgical Arm Boards	Mizuho Orthopedic Systems Inc			1987-02-06
K870098	Lithotomy Holders	Mizuho Orthopedic Systems Inc	FWZ	Class I	1987-02-06
K870056	Tecnol Classic Cone Mask	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1987-02-06
K870015	Hci All Purpose Drain/catheter Set	Health Care Innovations, Inc.	GBS	Class I	1987-02-06
K870014	Hci General Purpose Catheter Stylet	Health Care Innovations, Inc.	KGZ	Class I	1987-02-06
K865060	i.v. Set with Dual-Channel Cassette	Abbott Medical	FRN	Class II	1987-02-06
K865059	i.v. Set W/single-Channel Cassette	Abbott Medical	FRN	Class II	1987-02-06
K865058	Abbott Lifecare (R) 5000, Pump System	Abbott Medical	FRN	Class II	1987-02-06
K865021	Bactec(r) Nr-660 High Performance System	BD Becton Dickinson Vacutainer Systems Preanalytic	JTA	Class I	1987-02-06
K865009	A-Bec 47	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865008	A-Bec 17	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865007	A-Bec 15	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865006	A-Bec 14	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865005	A-Bec 41	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865004	A-Bec 40 Power Wheelchair	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865003	A-Bec 46	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865002	A-Bec 18	A-Bec Mobility, Inc.			1987-02-06
K865001	A-Bec Fireball 40	A-Bec Mobility, Inc.	ITI	Class II	1987-02-06
K865000	Immpulse Coated Tube Phenobarbital Assay Reagents	Sclavo, Inc.	LET	Class II	1987-02-06
K864800	Namic Chiba Aspiration Biopsy Needle	North American Instrument Corp.	GAA	Class I	1987-02-06
K864671	Anatomic Modular Knee (Amk) System	Depuy, Inc.	JWH	Class II	1987-02-06
K864664	H-1 Setpoint Platelet and Rbc/wbc Calibrators	Technicon Instruments Corp.	KSA	Class II	1987-02-06
K864542	Artel Differential Photometer	Artel, Inc.	JJQ	Class I	1987-02-06
K864534	Electra(r) 800 Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	JPA	Class II	1987-02-06
K864532	Electra(r) 700 Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	JPA	Class II	1987-02-06
K864451	UV Visible Spectrophotometers	Trans-National Trade Development Corp.	JJQ	Class I	1987-02-06
K864448	The Biosonics Continence Control System Ccs(tm)	Biosonics, Inc.	KPN	Class II	1987-02-06
K864444	Shea Cupped Torp with Hydroxylapatite Flange	Richards Medical Co., Inc.	ETA	Class II	1987-02-06