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 1825 of 3531

510(k) clearances, page 1825 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980361	Dermablate Er: Yag Laser System	Aesculap-Meditec North America	GEX	Class II	1998-04-21
K980245	Nitom Locking Facebow	Ortho Kinetics Corp.	DZB	Class II	1998-04-21
K980214	Excel Neuro Works	Excel Tech., Ltd.	GWQ	Class II	1998-04-21
K980033	Ferno Healthcare Recline-a-Bath 2	Ferno-Washington Inc	ILJ	Class II	1998-04-21
K974842	Immulite 2000 3Rd Generation Psa	Siemens Healthcare Diagnostics Inc.	LTJ	Class II	1998-04-21
K974602	Optical Tracking System (Ots)	Radionics Software Applications, Inc.	HAW	Class II	1998-04-21
K974382	Ackermann Surgical Instruments	Ackermann Instrumente GmbH	GCJ	Class II	1998-04-21
K974371	Clk Int'l Powder Free Latex Examination Glove	Clk Intl., Inc.	LYY	Class I	1998-04-21
K974057	Dentek Ld 15 Lasersystem	Dentek Lasersystems Produktions Ges.M.B.H.	GEX	Class II	1998-04-21
K973896	Ohmeda Excel 3000 Anesthesia System	GE Healthcare	BSZ	Class II	1998-04-21
K972548	Slt Cl Md Contact Laser System	Surgical Laser Technologies, Inc.	GEX	Class II	1998-04-21
K965071	Detachable Slicone Balloon (Dsb)	Target Therapeutics	MZQ	Class II	1998-04-21
K964488	Detachable Silicone Balloon (Dsb)	Target Therapeutics	MZQ	Class II	1998-04-21
K980864	Power Coins Glow in the Dark Ligatures	Ortho Kinetics Corp.	ECI	Class I	1998-04-20
K980657	Ahmed Glaucoma Valve, Model S3	New World Medical, Inc.	KYF	Class II	1998-04-20
K980165	Infutest 2000 Infusion Device Analyzer	Datrend Systems Inc	MRZ	Class II	1998-04-20
K973639	Electrode Semi-Flotation Catheter by J-Lloyd Medical, Inc.	J-Lloyd Medical, Inc.	DRF	Class II	1998-04-20
K971504	Hexapolar Electrode Balloon Flotation Catheter	J-Lloyd Medical, Inc.	DRF	Class II	1998-04-20
K971407	Jtech Commander and Algometer	J-Tech Medical, Inc.	HRW	Class I	1998-04-20
K980587	IV Decanter-Flexible	Inrad	LHI	Class II	1998-04-17
K980581	Planmeca Dixi, Digital Intraoral X-Ray Imaging System	Planmeca Oy	EHD	Class II	1998-04-17
K980296	Oldelft Digidelca	Oldelft Corp. of America	KPR	Class II	1998-04-17
K980204	Durex Latex Condoms	London Intl., LLC	HIS	Class II	1998-04-17
K980199	Synthes 1.5Mm/2.0mm Orthognathic Maxillary Plates and Screws	Synthes (USA) Products LLC	DZL	Class II	1998-04-17
K974315	Vidar Vxr Ls Laser Film Digitizer	Vidar Systems Corp.	LMA	Class II	1998-04-17
K964001	Swartz Doppler Flow Probe and Monitor System	Med Institute, Inc.	ITX	Class II	1998-04-17
K961486	Ivac Medsystem III, Infusion Pump W/drug Editing Software Kit	Ivac Medical Systems	MRZ	Class II	1998-04-17
K981165	Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test	Germaine Laboratories, Inc.	JHI	Class II	1998-04-16
K981106	Urea Nitrogen (Bun) Liquid Reagent	Teco Diagnostics	CDQ	Class II	1998-04-16
K981100	Stratus Cs Trop Calpak	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1998-04-16
K981097	Stratus Cs Ckmb Calpak	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1998-04-16
K981038	Coamatic Factor VIII	Instrumentation Laboratory Co.	GGP	Class II	1998-04-16
K980982	Avocet System Liquid Control Level 1 and Level 2	Avocet Medical, Inc.	GGN	Class II	1998-04-16
K980736	Acon Hcg One Step Urine/serum Pregnancy Test	Acon Laboratories, Inc.	JHI	Class II	1998-04-16
K980473	Press-Fit Stem	Encore Orthopedics, Inc.	LZO	Class II	1998-04-16
K980395	Gladrags Cotton Menstrual Pad	Keepers!, Inc.	HHD	Class I	1998-04-16
K980363	Oro-Facial Myographic Measurement Instrument (Ommi)	Orofacial Dynamics	LBB	Class II	1998-04-16
K980358	Synthes Spine Posterior Cervical/thoracic Hook/rod System	Synthes (USA) Products LLC	KWP	Class II	1998-04-16
K980356	Cervical Cytology C-Brush Model Cmb-1010	Canadian Medical Brush, Inc.	HHT	Class II	1998-04-16
K980327	Microstream Filterline ICU	Oridion Medical, Ltd.	CCK	Class II	1998-04-16
K980325	Microstream Nasal Cannula Filterline	Oridion Medical, Ltd.	CCK	Class II	1998-04-16
K980324	Microstream Fillerline Or/ems	Oridion Medical, Ltd.	CCK	Class II	1998-04-16
K980305	Amt Button Replacement Gastrostomy Device	Applied Medical Technology Inc	KNT	Class II	1998-04-16
K980239	Partnership Calcar Femoral Components	Howmedica Corp.	LZO	Class II	1998-04-16
K980164	Sterichek Peracetic Acid Reagent Strips	Environmental Test Systems, Inc.	MSY	Class II	1998-04-16
K974776	Mda D-Dimer	bioMerieux, Inc.	DAP	Class II	1998-04-16
K974408	Proclear (Omafilcon a) Daily Wear Contact Lens	Biocompatibles Eyewear, Inc.	LPL	Class II	1998-04-16
K974341	Mitek Btb Absorbable (Pla) Cross Pin	Mitek Products	HTY	Class II	1998-04-16
K973775	Harpoon Suture Anchors	Zimmer GmbH	MBI	Class II	1998-04-16
K972800	Pta Balloon Catheter	Cook Inc.	LIT	Class II	1998-04-16