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 2026-10-26, 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 2763 of 3530

510(k) clearances, page 2763 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875259	Bitek(tm) Blood Culture System	Definitive Diagnostics, Inc.	JSG	Class I	1988-01-27
K875162	Ortho* Specimen Collection Cytology Brush	Ortho Diagnostic Systems, Inc.	HHT	Class II	1988-01-27
K875147	Torque Hex Wrench	Cardiac Pacemakers, Inc.	DTF	Class I	1988-01-27
K874964	Dental Hand Instruments	Solway, Inc.	EKJ	Class I	1988-01-27
K874682	Mmg Catheter Plug W/drainage Tube Cover	Medical Marketing Group	KOD	Class II	1988-01-27
K874644	Steam Autoclave Control. & Datalog. by Datacon	Pharmetics, Inc.	FLE	Class II	1988-01-27
K874607	Four Liter Bag for Use W/redy 2000/Dialert Systems	bioMerieux, Inc.	LKN	Unclassified	1988-01-27
K874530	Urethral Dilator Endoscope	Advanced Surgical Intervention, Inc.	KOB	Class II	1988-01-27
K874512	Modified Biovac:lfa Laser Fume Evacuation System	Stackhouse Assoc.	FYD	Class II	1988-01-27
K874447	Disposable Gel Defibrillation/external Pacing Elec	Medac, Inc.	DRO	Class II	1988-01-27
K874411	Donaldson Natural Eyepatch 'Patient Pak'	Keeler Instruments, Inc.	HMP	Class I	1988-01-27
K874354	Audiometric Impedance Tester, Model Z02020	Madsen Electronics (Canada), Ltd.	ETY	Class II	1988-01-27
K874320	Cellect Labtrak Software	Instrumentation Laboratory Co.	GKL	Class II	1988-01-27
K874252	Kreda Disc	Richmond Products, Inc.	HOQ	Class I	1988-01-27
K874203	Amerlite Ferritin Assay, Lan.0800/1800/2800	Amersham Corp.	DBF	Class II	1988-01-27
K874160	Zeiss 40 Sl/p Photo Slit Lamp	Carl Zeiss, Inc.	HJO	Class II	1988-01-27
K874093	Sls-88 Total Hip System, Acetabular Cup	Protek, Inc.	JDI	Class II	1988-01-27
K873726	Acid Phosphatase Test	King Diagnostics, Inc.	CKE	Class II	1988-01-27
K873695	Model 1859 Tumi/pressure Module	Life-Tech Intl., Inc.	EXY	Class II	1988-01-27
K873602	Intermedics' Natural-Knee(r) Revision System	Intermedics Orthopedics	JWH	Class II	1988-01-27
K872178	Modification to Arkive(tm)	Diatek, Inc.	BSZ	Class II	1988-01-27
K871850	Teleflex Steerable Guidewire	Teleflexmedical, Inc.	DQX	Class II	1988-01-27
K875067	Good Looks Dazzlers	Mel Appel	HQY	Class I	1988-01-26
K874868	Opti-Fix Collared Femoral Components	Richards Medical Co., Inc.	JDG	Class II	1988-01-26
K874355	Opacity Lensmeter 701	Intraoptics, Inc.	HKI	Class II	1988-01-26
K875319	Nsn #6515-00-690-3209 Debakey Tissue Forceps	I-Tech Industries SRL	GEN	Class I	1988-01-22
K875291	Spinal Surgery Frame	T. Korossurgical Instruments Corp.	BWN	Class I	1988-01-22
K875289	Suction Retractor	T. Korossurgical Instruments Corp.	GAD	Class I	1988-01-22
K875273	Bitek(tm) Blood Culture System	Definitive Diagnostics, Inc.	JSG	Class I	1988-01-22
K875268	Tmm Model 2500 Capmonitor	Traverse Medical Monitors	CCK	Class II	1988-01-22
K875261	Kimberly-Clark Full Coverage Hood	Kimberly-Clark Corporation	FYF	Class I	1988-01-22
K875222	Total Protein	Catachem, Inc.	CEK	Class II	1988-01-22
K875194	Kleenspec Disposable Face Shield, Model 57001	Welch Allyn Inc	FXX	Class II	1988-01-22
K875172	Disposable Surgical Face Mask	Irema USA, Ltd.	FXX	Class II	1988-01-22
K875165	Qm300 Lambda Light Chains Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DEH	Class II	1988-01-22
K875164	Qm300 Kappa Light Chains Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DFH	Class II	1988-01-22
K875043	Rongeur (Neurosurgical Instruments)	Solway, Inc.	HAE	Class II	1988-01-22
K875024	Dey-Pak and Dey-Vial Sodium Chloride Solution, Usp	Dey Laboratories, Inc.	CCQ	Class I	1988-01-22
K875019	Ghajar Guide System for the Perforator	Neurodynamics, Inc.	HBF	Class II	1988-01-22
K875011	Dey-Pak Purified Water, Usp, Sterile	Dey Laboratories, Inc.	CCQ	Class I	1988-01-22
K874736	Rich-Mar Hv-2000 Electrical Muscle Stimulator	Rich-Mar Corp.	IPF	Class II	1988-01-22
K874735	Dantec 13L35/36/37 Stim. and Recording Electrode	Dantec Electronics, Inc.	GXY	Class II	1988-01-22
K874552	Envisan Pad	Marion Laboratories, Inc.	KOZ	Class I	1988-01-22
K874551	Envinet(tm)	Marion Laboratories, Inc.	EFQ	Unclassified	1988-01-22
K874506	Use of Technicon Ra Systems Reagents on Assist(r)	Technicon Instruments Corp.	JGJ	Class I	1988-01-22
K874418	Lsp Disposable Bag Resuscitator, Model 470	Life Support Products, Inc.	BTM	Class II	1988-01-22
K874225	Bio-Cor Ext Collagen Corneal Shield	Bausch & Lomb Incorporated	MOE	Class I	1988-01-22
K874224	Bio-Cor II Collagen Corneal Shield	Bausch & Lomb Incorporated	MOE	Class I	1988-01-22
K874119	Interferential Current Unit	Compustim Electronics	LIH	Class II	1988-01-22
K873819	Modified Stress Machine	S.J.F., Inc.	ISA	Class I	1988-01-22