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 1852 of 3531

510(k) clearances, page 1852 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963391	Speculite	Trylon Corp.	MPU	Class II	1997-12-12
K974261	Accurun 135 Toxoplasma Igg Positive Control	Boston Biomedica, Inc.	LJK	Class II	1997-12-11
K974181	Accusign Doa 2, Accusign Doa, Accusign Bar/bzo, Biosign Doa 2, Biosign Bar/bzo, First Check Panel 2 Bar/bzo, Status Ds B	Princeton BioMeditech Corp.	JXM	Class II	1997-12-11
K973927	Hyunjae Corporation - Nusil Earmold Impression Material	Hyunjae Corp.	ESD	Class I	1997-12-11
K973871	Low Powder Polymer Latex Examination Gloves (with Protein Labeling Claim)	Hartalega Sdn Bhd	LYY	Class I	1997-12-11
K973781	Aquasil Easy Mix Putty Impression Material	Dentsply Intl.	ELW	Class II	1997-12-11
K973778	Polymer Coated Powder-Free Latex Examination Gloves	Hartalega Sdn Bhd	LYY	Class I	1997-12-11
K973569	Sowell Nickel-Chrome-Molybdenum Alloy	C.K. International Trading	EJH	Class II	1997-12-11
K973568	Sowell Nickel-Chrome Non-Precious Metal Alloy	C.K. International Trading	EJH	Class II	1997-12-11
K973567	Sowell Cobalt-Chrome Metal Alloy	C.K. International Trading	EJH	Class II	1997-12-11
K973501	Expresse and Premier Powered Breast Pumps	Ameda Medizintechnik AG	HGX	Class II	1997-12-11
K972979	Smith & Nephew Images Cystourethroscopes and Accessories, Smith & Nephew Semi0rigid and Flexible Manual Surgical Instrum	Smith & Nephew, Inc.	FBO	Class II	1997-12-11
K972887	Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1997-12-11
K972744	Courier St Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1997-12-11
K972470	Crit-Line Monitor (Clmiii)	In-Line Diagnostics Corp.	MQS	Class II	1997-12-11
K972372	Germ Trapper Suction Tube Holder	Rzv Medical Specialties, Inc.	JOL	Class II	1997-12-11
K972280	Greatbatch Scientific Mr Compatible Laparoscopes and Operating Laparoscopes	Wilson Greatbatch Technologies, Inc.	GCJ	Class II	1997-12-11
K971688	Ivt 0.014 PTFE-Coated Trackwire	Boston Scientific /International Technologies	DQX	Class II	1997-12-11
K970277	Uridyltransferase Kit, 50 Hour (80-4000-13K)	Astoria-Pacific, Inc.	KQP	Class II	1997-12-11
K970078	Hydrofloex Hd Hysteroscopic Distention System	Davol Inc., Sub. C.R. Bard, Inc.	HIG	Class II	1997-12-11
K964663	Favp: Femoral Artery Vascular Pad - Model Number Pad2ek-01, Pad2ek-2X, Pad5ek-R, Pad5ek-Rx, Pad6ek-F and Pad6ek-Fx	Rmds, Inc.	DXC	Class II	1997-12-11
K974461	Triage Cardiac Controls, Triage Troponin-I Control, Triage Ck-Mb Control, Triage Myoglobin Control	Biosite Incorporated	JJT	Class I	1997-12-10
K973619	Kendall Curity Non-Adhering Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1997-12-10
K973580	Invotec Clean Pad	Invotec International, Inc.	EFQ	Unclassified	1997-12-10
K972329	Osmocyte Ra Wound Dressing	Procyte Corp.	KMF	Class I	1997-12-10
K972150	Osmocyte Island Wound Dressing	Procyte Corp.	KMF	Class I	1997-12-10
K972148	B.u.s. Endotron	Medicamat S.A.	LFL	Unclassified	1997-12-10
K970163	Alpha Mx (20)/Ultra Pc (30)	Technical Medical Products, Inc.	BSZ	Class II	1997-12-10
K974158	Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy	Ortho Development Corp.	KNW	Class II	1997-12-09
K973576	Epulse Model 2940 Er:aser Er:yag Laser System	Epulse Technologies, Inc.	GEX	Class II	1997-12-09
K973470	Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons	Lumenis Ltd	GEX	Class II	1997-12-09
K973461	Elite Powder Free Polyurethane Synthetic Surgical Glove	Ansell Perry	KGO	Class I	1997-12-09
K973453	Tornier Cement Restrictor	TORNIER Inc.	JDI	Class II	1997-12-09
K973438	Osteo Bos System Product Line Extension	Osteonics Corp.	HRS	Class II	1997-12-09
K973436	Vista Head Mounted Display	Vista Medical Technologies, Inc.	GCJ	Class II	1997-12-09
K973432	Surgiflator-30	Novanta Medical GmbH	HIF	Class II	1997-12-09
K973424	Enfresh Tongue Brush	Enfresh Products, LLC	LCN	Class I	1997-12-09
K973420	Clinitex Cast Padding	Clinitex Medical Corp.	LGF	Class I	1997-12-09
K973417	Clinitex Stockinette	Clinitex Medical Corp.	LGF	Class I	1997-12-09
K973083	Ultracell Neuro Sponges	Ultracell Medical Technologies, Inc.	HBA	Class II	1997-12-09
K972496	Pencil-Grip Fna Syringe Holder and Effortless Needle Remover	Tao & Tao Technologyt, Inc.	KNW	Class II	1997-12-09
K971580	Uas Ultrasonic Aspirator System	Wells Johnson Co.	LFL	Unclassified	1997-12-09
K970851	Lyoplant Dura Substitute(various)	Aesculap Inc	GXQ	Class II	1997-12-09
K965158	Heart Protector (Ver 1996)	N.P.N.T., Inc.	DRT	Class II	1997-12-09
K974414	Multi	Morning Calm Corp.	HQY	Class I	1997-12-08
K974384	Elecsys Calcheck Folate	Boehringer Mannheim Corp.	JJY	Class I	1997-12-08
K974383	Elecsys Calcheck Vitamin B12	Boehringer Mannheim Corp.	JJX	Class I	1997-12-08
K974325	Chiron Diagnostics Acs:180 Myoglobin	Chiron Diagnostics Corp.	DDR	Class II	1997-12-08
K974053	Amylase-Sl Assay Catalogue Number 341-10	Sekisui Diagnostics P.E.I. Inc.	JFJ	Class II	1997-12-08
K973995	Randox Bilirubin	Randox Laboratories, Limited	GIG	Class II	1997-12-08