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 1957 of 3531

510(k) clearances, page 1957 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963142	Dca 2000 + Microalbumin/creatinine Assay	Bayer Corp.	JIR	Class I	1996-09-27
K963080	Testosteronee Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System)	Bayer Corp.	CDZ	Class I	1996-09-27
K963066	Mentor Injection Port Detector (Ipd)	Mentor	LCJ	Unclassified	1996-09-27
K963037	Patriot	Infimed, Inc.	LLZ	Class II	1996-09-27
K962890	Cholesterol-Incorporating Dynamic Stab Tech (Dst)	Trace Scientific, Ltd.	CHH	Class I	1996-09-27
K962613	Darpac 2000 Superficial X-Ray Therapy System	Gulmay Medical, Ltd.	JAD	Class II	1996-09-27
K962596	Customed Blood Extraction Kit	Customed, Inc	GJE	Class II	1996-09-27
K962033	Chemiluminescence Intra-Operative Intact Pth Kit	Nichols Institute Diagnostics	CEW	Class II	1996-09-27
K961815	Qualitrol Ana Control Serum Set	Consolidated Technologies, Inc.	LKJ	Class II	1996-09-27
K961674	Roche Unimate Fructosamine Reagent	Roche Diagnostic Systems, Inc.	LCP	Class II	1996-09-27
K960964	Ohmeda 7900 Anesthesia Ventilator	GE Healthcare	CBK	Class II	1996-09-27
K953044	Unipolar & Bioplar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation & Passive Fixation	BIOTRONIK AG	DTB	Class III	1996-09-27
K950264	Maglife	Odam	MHX	Class II	1996-09-27
K963508	Dispens-O-Disc Meropenem	Difco Laboratories, Inc.	JTN	Class II	1996-09-26
K962202	Quantex Igg	Instrumentation Laboratory Co.	DEW	Class II	1996-09-26
K962198	Quantex C4	Instrumentation Laboratory Co.	DBI	Class II	1996-09-26
K960902	Eureduc Pneumatic Drainage System Model Tp03	Eureduc	JOW	Class II	1996-09-26
K962979	S-53 Introral Dental System	Del Medical Systems Corp.	DZA	Class I	1996-09-25
K962927	In-Room Mrc/ Magnetom Vision and Impact Systems	Siemens Medical Solutions USA, Inc.	LNH	Class II	1996-09-25
K962878	Targis System	Ivoclar North America, Inc.	EBF	Class II	1996-09-25
K962757	J.b.s. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp	J.B.S., S.A.	MNH	Class II	1996-09-25
K962561	Supracondylar Intramedullary Nail	Zimmer GmbH	HSB	Class II	1996-09-25
K962552	Ez-6 Proximal Humeral Interamedullary Rod System	Biodynamic Technologies, Inc.	HSB	Class II	1996-09-25
K962201	Quantex Igm	Instrumentation Laboratory Co.	DFT	Class II	1996-09-25
K962200	Quantex Iga	Instrumentation Laboratory Co.	CZP	Class II	1996-09-25
K962199	Quantex C3	Instrumentation Laboratory Co.	CZW	Class II	1996-09-25
K961771	Auto Suture Surgiwand	United States Surgical, A Division of Tyco Healthc	GEI	Class II	1996-09-25
K961387	Mt-X	The Emerging Technologies Group	DZE	Class II	1996-09-25
K961386	Mt-2A	The Emerging Technologies Group	DZE	Class II	1996-09-25
K961385	Mt-3A	The Emerging Technologies Group	DZE	Class II	1996-09-25
K961384	Mt-2	The Emerging Technologies Group	DZE	Class II	1996-09-25
K961383	Mt1	The Emerging Technologies Group	DZE	Class II	1996-09-25
K961382	Mt1a	The Emerging Technologies Group	DZE	Class II	1996-09-25
K953567	Incstar 25-Hydroxyvitmin D 1251 Ria	Incstar Corp.	MRG	Class II	1996-09-25
K952975	Ankle Calf Exerciser Phlebopump	Prevent Products, Inc.	BXB	Class I	1996-09-25
K963359	Insufflation Needle	Applied Medical Resources Corp	HET	Class II	1996-09-24
K962542	Air Motor Handpiece Tn-102	Nsk Nakanishi, Inc.	EFB	Class I	1996-09-24
K961550	Qualitrol Mono Control Serum Set	Consolidated Technologies, Inc.	KTN	Class II	1996-09-24
K961545	Qualitrol RF Controls	Consolidated Technologies, Inc.	DHR	Class II	1996-09-24
K961544	Qualitrol Igame Controls, Levels 1 and 2	Consolidated Technologies, Inc.	DGR	Class I	1996-09-24
K961312	Hemocue B-Hemoglobin System	HemoCue AB	GKR	Class II	1996-09-24
K960337	Amd Home Health Monitoring System	Advanced Medical Devices, Inc.	CGA	Class II	1996-09-24
K954045	Axsym Rubella Igg Antibody Assay	Abbott Medical	LFX	Class II	1996-09-24
K963383	Hichem Alp/amp Reagent Kit	Hichem Diagnostics	CKF	Class II	1996-09-23
K963300	Dbc Acupunture Needles(several Types Are Described on the Following Pages)	Lhasa Medical, Inc.	MQX	Class II	1996-09-23
K963246	Trebay Microdebrider or Xps Straight Shot	Medtronic Xomed, Inc.	ERL	Class II	1996-09-23
K963244	Acetaminophen Flex Reagent Cartridge	Dade Intl., Inc.	LDP	Class II	1996-09-23
K963175	Glycar Tissue Repair Patch, Bio-Patch, Uro-Sling	Glycar SA Pty., Ltd.	FTM	Class II	1996-09-23
K963039	Sureskin Standard, Border, and Thin	Euromed, Inc.	FRO	Unclassified	1996-09-23
K962888	Affirm One-Step Home Pregnancy Test	Athena Medical Corp.	LCX	Class II	1996-09-23