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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2314 of 3531

510(k) clearances, page 2314 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930802	Models 642 & 643 Tilt Exam/treatment Table	Tri W-G, Inc.	INQ	Class I	1993-03-22
K926559	Proact Biopsy Needle Enchancements	Proact, Ltd.	FCG	Class II	1993-03-22
K926054	Eld-Arondak Chair	Al'S Woodcraft, Inc.	INM	Class I	1993-03-22
K926053	Eld-Arondak Chair	Alert Care, Inc.	INM	Class I	1993-03-22
K926025	Chairs	Theradapt Products Inc.	INM	Class I	1993-03-22
K925926	Mobilimb T1 Toe Cpm Unit	Toronto Medical Corp.	BXB	Class I	1993-03-22
K925901	Kinemax(r) Condylar Total Knee Syst Femoral Spacer	Howmedica Corp.	JWH	Class II	1993-03-22
K925783	Autostat Anti-Dsdna	Cogent Diagnotics, Ltd.	JJX	Class I	1993-03-22
K925527	Light Talker	Prentke Romich Co.	ILQ	Class II	1993-03-22
K925127	Alta Cancellous Bone Screw	Howmedica Corp.	KTT	Class II	1993-03-22
K924484	Artromot Multi Directional Ankle Cpm	Buckman Co., Inc.	BXB	Class I	1993-03-22
K924456	Long Length Percutaneous Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	1993-03-22
K923710	Oscillair 3000 Low Air Loss Kinetic Therapy Bed	Progressive Medical Technology, Inc.	IKZ	Class II	1993-03-22
K923483	Bard William Harvey Aortic Arch Canulae	C.R. Bard Inc	DWF	Class II	1993-03-22
K923364	Tilt Adjustable Sliding Back Recline Seating Syst	Labac Systems, Inc.	KNN	Class I	1993-03-22
K921658	Anti-Dsdna Antibody Test	Immco Diagnostics, Inc.	LSW	Class II	1993-03-22
K920446	Total Toe System	Zimmer GmbH	LZJ	Unclassified	1993-03-22
K915369	The Equalizer	Advanced Rehabilitative Technology, Inc.	IKE	Class I	1993-03-22
K923233	Cardio-Pak Laparotomy Pack	Cardio-Med-Associates, Inc.	FZH	Class II	1993-03-20
K922896	Vital-Port Vascular Access System W/ Injectrol	Med Institute, Inc.	LJT	Class II	1993-03-20
K922648	Ace Custom Surgical Pack	Ace Surgical Supply Co., Inc.	LRO	Class II	1993-03-20
K922213	Laser-Assisted Disk Decompression Accessory Pack	Trimedyne, Inc.	GEX	Class II	1993-03-20
K920615	Anago Continuous Epidural Anesthesia Tray/kit	Anago, Inc.	CAZ	Class II	1993-03-20
K930292	House-Bellucci Alligator Scissors	Thomasville Medical Assoc.	LRC	Class I	1993-03-19
K930114	Tracheostomy T-Tube	Invotec International, Inc.	BTR	Class II	1993-03-19
K930090	Helicat	Elscint, Inc.	JAK	Class II	1993-03-19
K926158	Slater Sleeve	Tadco, Inc.	CCW	Class I	1993-03-19
K926072	K-Band and K-Crepe	Parema, Ltd.	NAB	Class I	1993-03-19
K926011	A-Port Implant Vascu Access Syst Prod Lin Ext-Modi	Therex Corp.	LJT	Class II	1993-03-19
K925277	Ciba Corning Acs Hcg Immunoassay	Ciba Corning Diagnostics Corp.	JHI	Class II	1993-03-19
K924889	Zefon Adult Anesthesia Breathing Circuit	Zefon Medical Products	CAI	Class I	1993-03-19
K924120	Molded Fiber Cap Delivery System	Lca, Inc.	GEX	Class II	1993-03-19
K924100	Oxygen Concentrator	Allied Medical LLC	CAW	Class II	1993-03-19
K923922	Surgical Spears	Ultracell Medical Technologies, Inc.	HOZ	Class II	1993-03-19
K923708	Lempert Optic Disc Analysis System	Lempert Ophthalmic Instruments	HKI	Class II	1993-03-19
K923477	3.5Mm Universal Compression Screw	Howmedica Corp.	HWC	Class II	1993-03-19
K922370	New Editions Childrens Sunglasses	Fishel Toys, Ltd.	HQY	Class I	1993-03-19
K930853	Intra V and Secret Ear III	Starkey Laboratories, Inc.	ESD	Class I	1993-03-18
K930805	Ce-9 in-the-Ear Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1993-03-18
K930715	Widex Model Dx Hearing Aid	Widex Hearing Aid Co., Inc.	ESD	Class I	1993-03-18
K930640	Precise Pregnancy	BD Becton Dickinson Vacutainer Systems Preanalytic	LCX	Class II	1993-03-18
K930598	Otosonic Fsd, in-the-Ear Hearing Aid	Beltone Electronics Corp.	ESD	Class I	1993-03-18
K930313	Apex Specimen Bag	Apex Medical Technologies, Inc.	LIO	Class I	1993-03-18
K930271	Behind-the-Ear Hearing Aid	Audina Hearing Instrument, Inc	ESD	Class I	1993-03-18
K926563	Autobead(tm) T4 Enzyme Immunoassay Test Kit	Bio-Chem Laboratory Systems, Inc.	CDX	Class II	1993-03-18
K926550	Unix-Link	General Electric Co.	IYX	Class I	1993-03-18
K926434	Sis-300(N)-Dia Scan	Micro-Focus Imaging., Inc.	JAA	Class II	1993-03-18
K926397	Fast Spin Echo Measuring Function	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1993-03-18
K926356	Precise(tm) Hcg(urine/serum) and Prcise(tm) Preg	Becton Dickinson Advanced Diagnostics	JHI	Class II	1993-03-18
K926261	Jpi Aluminum Interspaced X-Ray Grid	Jpi, Inc.	IXJ	Class I	1993-03-18