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 2350 of 3531

510(k) clearances, page 2350 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922848	Ultralite X-Ray Film Illuminator	A & S Trading Co.	IXC	Class I	1992-09-28
K922828	Ulcer Wound Tray	Ulti-Med Intl., Inc.	KKX	Class II	1992-09-28
K922583	Bartels Herpes Simplex Virus 2 Igg Eia	Baxter Diagnostics, Inc.	LGC	Class II	1992-09-28
K922426	Summit Nuclear Vision T-22 Gamma Camera System	Summit Nuclear	KPS	Class II	1992-09-28
K921863	Sonos 500, 1000, 1500/Sonos or Ultrasound Imag Sys	Hewlett-Packard Co.	GXW	Class II	1992-09-28
K921600	Ultradent Prod Li Cured Pit/fissure Seal Prod Line	Ultradent Products Inc.	EBC	Class II	1992-09-28
K921599	Ultradent Product Dentin Condition & Seal Prod Lin	Ultradent Products Inc.	EBC	Class II	1992-09-28
K921424	Sil-Med Flat Suction Drain	Sil-Med Corp.	GBX	Class I	1992-09-28
K921270	Safe-Dwell Plus Central Venous Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	FOZ	Class II	1992-09-28
K921045	Diaslide Urine Culturing Device	Savyon Diagnostics Ltd.	JXA	Class I	1992-09-28
K920763	Lacerattion Tray	Sterile Concepts, Inc.	KDD	Class I	1992-09-28
K915338	Conductive Surgigrip Spiral Sleeve	United States Surgical, A Division of Tyco Healthc	HET	Class II	1992-09-28
K924056	Encore Rheumatoid Factor Eia	Trinity Biotech USA	DHR	Class II	1992-09-25
K923886	Diastat Total Anti-Cardiolipin Kit	Shield Diagnostics, Ltd.	MID	Class II	1992-09-25
K923740	Kodak Amerlite Total Thyroid Control Sera	Eastman Kodak Company	JJY	Class I	1992-09-25
K923133	Affirm/vp Ident.test G.vaginalis & T.vaginalis	Microprobe Corp.	MJM	Class I	1992-09-25
K922457	Affirm Vp Microbial Id Test for Trichomonas Vagina	Microprobe Corp.	MJK	Class I	1992-09-25
K921462	Microtrak(r) II Chlamydia Eia Assay	Syva Co.	LJC	Class I	1992-09-25
K921399	Occlusion Ballon Catheter Modificaion	Interventional Therapeutics Corp.	DXC	Class II	1992-09-25
K921355	Wingmaster	Innovators, Inc.	EHB	Class I	1992-09-25
K921354	Blunt Tip Irrigation Needles	Innovators, Inc.	EKJ	Class I	1992-09-25
K920503	Syva Microtrak Chlamydia Eia	Syva Co.	LJC	Class I	1992-09-25
K920001	Hemolab Silimat Reagent	Biomerieux Vitek, Inc.	GFI	Class I	1992-09-25
K915622	Plato Brachytheraphy Treatment Planning System	Nucletron-Oldelft Corp.	JAQ	Class II	1992-09-25
K914053	System 350	Stryker Corp.	CAC	Class II	1992-09-25
K913242	Microprocessed Controlled Laparoflator	Bryan Corp.	HIF	Class II	1992-09-25
K924407	Conveen(r) Self-Sealing Urisheath Male Exter Cath	MEDLINE INDUSTRIES, LP - Northfield	EXJ	Class I	1992-09-23
K924270	Breast Lesion Localization Needle	Core Medical, Inc.	GDF	Class I	1992-09-23
K923687	One Directional Cleaning Brush	Endoscopy Support Services, Inc.	FEB	Class II	1992-09-23
K923672	Cox Disposable Endoscope Cleaning Brush	Cox Medical Ent., Inc.	FEB	Class II	1992-09-23
K923493	Life-Tel T.r.s.	Raco Products Co.	DXH	Class II	1992-09-23
K923489	Cox Disposable Retrieval Devices	Cox Medical Ent., Inc.	OCZ	Class II	1992-09-23
K923421	Coulter Beta-2 Microglobulin Immunoassay	Coulter Corp.	JZG	Class II	1992-09-23
K923296	Bte Hearing Aid Club Model St70	Club Hearing Instruments A/S	ESD	Class I	1992-09-23
K923295	Itc Hearing Aid Club Model Lm40	Club Hearing Instruments A/S	ESD	Class I	1992-09-23
K923294	Bte Hearing Aid Club Model: St60	Club Hearing Instruments A/S	ESD	Class I	1992-09-23
K923293	Itc Hearing Aid Club Model Lm50h	Club Hearing Instruments A/S	ESD	Class I	1992-09-23
K923258	Technicon Immuno 1 System Total Triiodothyronine	Kulzer GmbH	CDP	Class II	1992-09-23
K923240	Baxter Sensor Coronary Guidewire	Baxter Healthcare Corporation	DQX	Class II	1992-09-23
K923137	Csl X-Ray Imagescope	Csi Opto-Electronics Corp.	JAA	Class II	1992-09-23
K923114	Head Restraint for CT Tables	Cook, Inc.	JAK	Class II	1992-09-23
K923112	Angio-Band	Cook, Inc.	IZI	Class II	1992-09-23
K923111	Arm Extender for CT Tables	Cook, Inc.	JAK	Class II	1992-09-23
K923110	Scan Band	Cook, Inc.	JAK	Class II	1992-09-23
K923109	Adult Chin Strap for CT Tables	Cook, Inc.	JAK	Class II	1992-09-23
K923108	Wrist Restraint for Ge9800 c.t. Tables	Cook, Inc.	JAK	Class II	1992-09-23
K923075	3M Laser Imager Model 969	3M Medical Products Group	LMC	Class II	1992-09-23
K923074	Danplex Screening Audiometer	Life-Tech Intl., Inc.	EWO	Class II	1992-09-23
K923018	Encore Test Strips	Kulzer GmbH	CFR	Class II	1992-09-23
K922971	No-Scalpel Vascetomy Instruments	Pilling Co.	KOA	Class I	1992-09-23