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 2685 of 3530

510(k) clearances, page 2685 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884693	Universal(tm) Ion Select Electrode Standards	Biomedical Research & Development Laboratories, Inc.	JIX	Class II	1988-12-15
K884424	Lyphochek Routine Urine Controls 1 & 2 (Human)	Bio-Rad	JJW	Class I	1988-12-15
K884348	Modified Jeltrode(tm) Electrodes Deemed	Henley Intl.	GXY	Class II	1988-12-15
K884278	Implantable Electrode Leads 033-400,402 and 436	Telectronics, Inc.	DTB	Class III	1988-12-15
K884224	Total Bilirubin Reagent Kit for Astra Systems	A-Kem, Inc.	CIG	Class II	1988-12-15
K884152	Century Color Trace	Biomedical Systems Corp.	DSI	Class II	1988-12-15
K883925	Uroimager	Ausonics Pty, Ltd.	IYO	Class II	1988-12-15
K883726	Thyroid Stimulating Hormone (Htsh) Irma Neonatal	Immuchem Corp.	JLW	Class II	1988-12-15
K883533	Abc Fp Analyzer	Intl. Bioclinical, Inc.	JJE	Class I	1988-12-15
K883334	Biodop(tm)	Diagnosis Related Systems, Inc.	HEK	Class II	1988-12-15
K882447	Epstein-Barr Virus Early Antigen (Ea) Antibody Tes	Zeus Scientific LLC	LSE	Class I	1988-12-15
K882440	Epstein-Barr Virus Nuclear Antigen Antibody Test	Zeus Scientific LLC	LLM	Class I	1988-12-15
K884649	Total Iron Binding Capacity Test	Sclavo, Inc.	JQE	Class I	1988-12-14
K884377	Aspartate Aminotransferase Test Item No. 65654	Em Diagnostic Systems, Inc.	CIT	Class II	1988-12-14
K884258	Versablot	American Bionetics, Inc.	KPA	Class I	1988-12-14
K884201	Fiagen Tbg Time-Resolved Fluoroimmunoassay Kit	Cyberfluor, Inc.	CEE	Class II	1988-12-14
K884197	Document(tm) Cholesterol Calibrator Set	Casco Standards	JIT	Class II	1988-12-14
K884111	Pumpette(tm)	Helena Laboratories, Corp.	JKA	Class II	1988-12-14
K883559	Delfia Thyroxine (T4) Kit	Pharmacia, Inc.	CDX	Class II	1988-12-14
K883389	Raichem(tm) Bilirubin Conjugate Standard	Reagents Applications, Inc.	JIW	Class II	1988-12-14
K883079	Wwds-005 Human Rectal Probe	Ausonics Pty, Ltd.	IYO	Class II	1988-12-14
K882731	Tab Pak	Dynex Trading Co.	NXB	Class I	1988-12-14
K882679	Slt Contact Laser System Cyclophotocoagulation	Surgical Laser Technologies, Inc.	HQB	Class II	1988-12-14
K884695	Washer 500 Microelisa System	bioMerieux, Inc.	JTC	Class I	1988-12-13
K884543	Lsp Demand Inhalator Valve Model Spoo68 W/mask	Sechrist Industries Inc	CBP	Class II	1988-12-13
K884318	Thermoset(tm) Closed Loop Delivery System	Abbott Medical	KRB	Class II	1988-12-13
K884198	Target Therapeutics Seeker-16 Steerable Guidewire	Target Therapeutics	DQX	Class II	1988-12-13
K884058	Coatest Protein C	Kabivitrum, Inc.	GGP	Class II	1988-12-13
K883983	Sanifix	Iberhospitex, S.A.	KGX	Class I	1988-12-13
K883976	Cfx 625	Fischer Imaging Corp.	IZO	Class I	1988-12-13
K883899	Manual Percussor Cups	Medical Components, Inc.	BYI	Class II	1988-12-13
K883832	Catheter, Intrauterine and Introducer	Telos Medical Corp.	KXO	Class II	1988-12-13
K883506	Irrigation Kit	L H M Ent., Inc.	KYZ	Class I	1988-12-13
K883487	Lyme Disease Ifa (Igg)	Hillcrest Biologicals	LSR	Class II	1988-12-13
K882657	Harbor S.e.a.-Port Surgical Accessory Kit	Harbor Medical Devices, Inc.	DYB	Class II	1988-12-13
K881841	Danninger Trimcheck(tm) Portable & Desk Top Models	Buckman Co., Inc.	DSB	Class II	1988-12-13
K884932	Invacare Youthmobile 5000 Series Wheelchair	Invacare GmbH	IOR	Class I	1988-12-12
K884931	Rolls 3000 Series Wheelchair (Youthmobile)	Invacare GmbH	IOR	Class I	1988-12-12
K884579	UV Air Sterilight	Allseasons Environmental Control, Inc.	FRA	Class II	1988-12-12
K884497	Control Syringe	Professional Medical Services	FMF	Class II	1988-12-12
K884272	Wooden Spectacle Frames	Woodwave	HQZ	Class I	1988-12-12
K884210	Tx-7 (TENS) (Ic-1107)	Oms Medical Supplies, Inc.	GZJ	Class II	1988-12-12
K884014	Flo-Gard Vp	Baxter Healthcare Corporation	FRN	Class II	1988-12-12
K883888	Cathscanner Intravascular Ultrasonic Imaging Syst.	Advanced Biosearch Assn.	DXK	Class II	1988-12-12
K883837	Mikado Ac 405	Ivex Medical, Inc.	CAW	Class II	1988-12-12
K882289	Aries 40Cc Percu. (D/l) Intra-Aortic Balloon Cath.	Aries Medical, Inc.	DSY	Class II	1988-12-12
K875187	Sdu-500 Diagnostic Ultrasound Instrument	Shimadzu Corp.	IYO	Class II	1988-12-12
K884790	Qualtex Neurolok Surgical Sponge	DeRoyal Industries, Inc.	GDY	Class I	1988-12-09
K884634	Modified Cedia Total T4 Assay	Microgenics Corporation	KLI	Class II	1988-12-09
K884589	Frantz Medical Sharps Collector	Franklin Medical USA, Inc.	FMF	Class II	1988-12-09