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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2663 of 3530

510(k) clearances, page 2663 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K891003	Latex Examination Gloves	Ruhn Chang Industrial Co., Ltd.	LYY	Class I	1989-03-17
K890812	Heads True Brush	Mcs Trading Co.	EFW	Class I	1989-03-17
K890811	Rx Apf (Casting Alloy)	Jeneric/Pentron, Inc.	EJS	Class II	1989-03-17
K890703	Custom in-the-Canal Hearing Aid Model: I52a	Oticon, Inc.	ESD	Class I	1989-03-17
K890599	Hood Nasal Splint	Hood Laboratories	EPP	Class I	1989-03-17
K890581	The Clark Lip Shield	American Orthodontics	EJF	Class I	1989-03-17
K890270	Auto Suture Absorbable Fascia Surgical Stapler*	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1989-03-17
K885208	Receptal Saf-Gard(tm) System	Abbott Medical	GCX	Class II	1989-03-17
K885189	Massaging Pick for Oral Hygiene	Dentek Corp.	JET	Class I	1989-03-17
K885017	Hemosorba Ch-500, Ch-350 and Ch-180	Asahi Kasei Medical MT Corp. Oita Works	FLD	Class II	1989-03-17
K884857	Colonoscope Guiding Tube Device	Mill-Rose Laboratory	FDF	Class II	1989-03-17
K884339	Toray Filtryzer Dialyzers	Toray Industries (America), Inc.	FJI	Class II	1989-03-17
K884223	Dental Lamp Handle Cover	Steri-Shield Products, Inc.	EAZ	Class I	1989-03-17
K884222	Curing Light Cover	Steri-Shield Products, Inc.	EBZ	Class II	1989-03-17
K884221	Ultrasonic Scaler Cover	Steri-Shield Products, Inc.	ELC	Class II	1989-03-17
K884220	Air Water Syringe Tip Shield	Steri-Shield Products, Inc.	EFS	Class I	1989-03-17
K884219	Bracket Table Arm Cover	Steri-Shield Products, Inc.	EIA	Class I	1989-03-17
K883842	Dental Alginate Impression Material W/anti. Addi.	Dentsply Intl.	ELW	Class II	1989-03-17
K882746	Adms Silent Needle Gun	Advanced Diagnostic Medical Systems, Inc.	KNW	Class II	1989-03-17
K891157	Defend Latex Examination Gloves	Carl Parker Associates, Inc.	LYY	Class I	1989-03-16
K891154	Spq(tm) Antibody Reagent Set II for Apo a-I/apo B	Atlantic Antibodies	MSJ	Class I	1989-03-16
K891065	Latex Examination Gloves	Modern Rubber Industrial Co., Ltd.	LYY	Class I	1989-03-16
K890991	Mono-Cube(tm)	Difco Laboratories, Inc.	KTN	Class II	1989-03-16
K890910	Plakof	Ximex, Ltd.	JET	Class I	1989-03-16
K890887	Abuscreen Fp for Cannabinoids	Roche Diagnostic Systems, Inc.	LDJ	Class II	1989-03-16
K890854	Eia Reader Model El301	Bio-Tek Instruments, Inc.	JJQ	Class I	1989-03-16
K890836	Ria-Gnost Progesterone	Cambridge Medical Technology	JLS	Class I	1989-03-16
K890793	Startrac	Unisen, Inc.	IOL	Class I	1989-03-16
K890747	Empi Reuseable Pin-Style TENS Electrode	Empi	GXY	Class II	1989-03-16
K890718	Gram Stain Control Slide	Scientific Device Laboratory, Inc.	LJG	Class I	1989-03-16
K890697	Ria-Gnost Ferritin	Cambridge Medical Technology	JMG	Class II	1989-03-16
K890694	Beta-2 Microglobulin Eia	Serex, Inc.	JZG	Class II	1989-03-16
K890670	Cryptosporidium Control Slide	Scientific Device Laboratory, Inc.	LJG	Class I	1989-03-16
K890614	Empi Multiday TENS Disposable Electrode	Empi	GXY	Class II	1989-03-16
K890609	Impres-Mb (Addition of an Optional Test Procedure)	Intl. Immunoassay Laboratories, Inc.	CGS	Class II	1989-03-16
K890605	Empi Island TENS Electrode	Empi	GXY	Class II	1989-03-16
K890601	Stuart Titanium Surgical Mesh	Stuart	EZX	Class II	1989-03-16
K890579	Tsh Microassay	Diamedix Corp.	JLW	Class II	1989-03-16
K890495	Nicolet Viking II System	Nicolet Instrument Corp.	IKN	Class II	1989-03-16
K890283	Cytex One and Cytex Two	Anderson Winn Paper Co.	HHT	Class II	1989-03-16
K890101	Femoral Angiography Drape	Medical Plastics, Inc.	KKX	Class II	1989-03-16
K885308	Electronic Digital Thermometer	Ewig Industries Co., Ltd.	FLL	Class II	1989-03-16
K885299	Sani-Sleeve Drape for Dental Use	Nieusma R & D, Inc.	EIA	Class I	1989-03-16
K885278	Epidural Anesthesia Tray	Preferred Medical Products, LLC	CAZ	Class II	1989-03-16
K885237	Acs Selective Infusion Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1989-03-16
K884660	Biosonic Ultrasonic Cleaning System	Whaledent Intl. Div. Ipco	FLG	Class I	1989-03-16
K884650	Resubmitted Scanora	Orion Corp.	IZF	Class II	1989-03-16
K884216	506 Non-Invasive Vital Signs Monitor	Criticare Systems, Inc.	DSI	Class II	1989-03-16
K883350	Reconditioned Astra(tm) 4	Associated Electro-Medical Services, Inc.	JJF	Class I	1989-03-16
K883298	Reconditioned Astra (Tm) 8	Associated Electro-Medical Services, Inc.	JJF	Class I	1989-03-16