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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3173 of 3528

510(k) clearances, page 3173 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830356	Titanium M.e. Muller Type Total Hip	Boehringer Mannheim Corp.	JDI	Class II	1983-03-09
K830351	Disposable Extrication Collar	Deip Enterprises, Inc.	IQK	Class I	1983-03-09
K830350	Cervical Pillow	Deip Enterprises, Inc.	IQK	Class I	1983-03-09
K830349	Sac-Ro-Form Insert & Binder	Deip Enterprises, Inc.			1983-03-09
K830348	Vinyl Extrication Collar	Deip Enterprises, Inc.	IQK	Class I	1983-03-09
K830336	Dorc Intraocular Electromagnet	JEDMED Instrument Company	HPO	Class II	1983-03-09
K830335	Dorc Corneal Punch Block	JEDMED Instrument Company	HNJ	Class I	1983-03-09
K830290	Dorc Contact/photo Deratoscope	JEDMED Instrument Company	HJA	Class I	1983-03-09
K830287	Zimmer Skin Protector	Zimmer GmbH	GAD	Class I	1983-03-09
K830285	Regnell Hydraulic Femoral Prothesis	Besco Financial Service	KFX	Class II	1983-03-09
K830255	Osteotomy Bone Staple	Techmedica, Inc.	HXJ	Class I	1983-03-09
K830245	Head Halter	Warm & Form, Orthopedic Materials	ILZ	Class I	1983-03-09
K830244	Traction Accessories	Warm & Form, Orthopedic Materials	HST	Class I	1983-03-09
K830229	Roentgenography Set	Mallinckrodt Critical Care	DGD	Class II	1983-03-09
K830218	Sheridan/esophageal Stethoscope	Sheridan Catheter Corp.	BZW	Class I	1983-03-09
K830216	Dorc Compact Micro Surgical System	JEDMED Instrument Company	HQE	Class II	1983-03-09
K830215	Dorc Lightweight Binocular Ophthalmoscop	JEDMED Instrument Company	HLJ	Class II	1983-03-09
K830214	Aft System III	Calbiochem-Behring Corp.	DHN	Class II	1983-03-09
K830193	Cat 3040	Burron Medical Products, Inc.	KPE	Class II	1983-03-09
K830185	Univ. Knee, Cutting Instrumentation	Intermedics Orthopedics			1983-03-09
K830161	Anesthesia Apatatus #D-25	W.E. Leder Enterprises, Inc.	BSZ	Class II	1983-03-09
K830160	Anesthesia Apparatus #Fo 20S	W.E. Leder Enterprises, Inc.	BSZ	Class II	1983-03-09
K830159	Anesthesia Apparatus Ph-35	W.E. Leder Enterprises, Inc.	BSZ	Class II	1983-03-09
K830143	Pneumatic Anterior Chamber Maintainer	Diversatronics, Inc.			1983-03-09
K830139	Endeco Acoustic Otoscope	Endeco Medical, Inc.	ETY	Class II	1983-03-09
K830056	Artec Twist Valve	Artec Environmental Monitoring Division	BTC	Class I	1983-03-09
K823906	Telemetry System	Transkinetic Systems, Inc.	DRG	Class II	1983-03-09
K823880	Bactigen-N. Meningitidis	Armkel, LLC	GTJ	Class II	1983-03-09
K823879	Cover-Roll Stretch	Beiersdorf, Inc.	NAB	Class I	1983-03-09
K823787	Handi-Wash	Dynatech Corp.	LIB	Class I	1983-03-09
K823726	Spectron Conversion Endoprosthesis Cup	Richard'S Medical Equip., Inc.	KWY	Class II	1983-03-09
K823724	Spectron Neck Replacement Prosthesis	Richard'S Medical Equip., Inc.	JDI	Class II	1983-03-09
K823723	Spectron Proximal Femoral Prosthesis	Richard'S Medical Equip., Inc.	JDI	Class II	1983-03-09
K823503	P-S Csf-Ventricular Catheter, Flanged	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1983-03-09
K823385	Ales	Oms	HPG	Class I	1983-03-09
K823362	Endomed 433	Kipp & Zonen			1983-03-09
K823077	Urinary Bladder Temp. Sensor #81-003	Clinical Technology Inc.	FLL	Class II	1983-03-09
K822735	Sure-Count Disposable Needle Counter	Geneva Laboratories, Inc.	MMK	Class II	1983-03-09
K830579	Multi-Signal Auditory Stimulator Sm700	Nicolet Biomedical Instruments	GWJ	Class II	1983-03-08
K830514	Millonigs Modified Phosphate Buffered	Surgipath Medical Industries, Inc.	IFP	Class I	1983-03-08
K830503	Ligaclip Titanium Ligating Clip	Ethicon, Inc	FZP	Class II	1983-03-08
K830396	Urea-Pda Disk	Remel Co.	JSS	Class I	1983-03-08
K830383	Fildes Enrichment Soluton	Gibco Laboratories Life Technologies, Inc.	KZI	Class I	1983-03-08
K830369	Power Flex	Biodynamic Technologies of Florida	BXB	Class I	1983-03-08
K830364	Neisseria Identification Discs	Oxoid U.S.A., Inc.	JSX	Class I	1983-03-08
K830352	Reinforced Silicone Tracheal Tube	Abbott Medical	BTR	Class II	1983-03-08
K830277	Duowipe Cautery Tip & Instrument Cleaner	Ritmed, Inc.	GEI	Class II	1983-03-08
K830275	Needelet Handler for Sharps	Ritmed, Inc.	MMK	Class II	1983-03-08
K830274	Floret Peanut Sponge/stick & Gauze Prep	Ritmed, Inc.	EFQ	Unclassified	1983-03-08
K830248	Devo'n Loops	Devon Industries, Inc.	KDC	Class I	1983-03-08