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 1865 of 3531

510(k) clearances, page 1865 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972789	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl600-0016	Alexander Mfg. Co.	DRT	Class II	1997-10-17
K972787	Alexander Manufacturing Co. Rechargeable Battery Part Number M850-P	Alexander Mfg. Co.	DRT	Class II	1997-10-17
K972786	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl9366	Alexander Mfg. Co.	DQA	Class II	1997-10-17
K972714	Siemens Multiview Workstation Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	DSI	Class II	1997-10-17
K972659	Dong Bang Acupuncture Needles	Dong Bang, U.S.A.	MQX	Class II	1997-10-17
K972658	Magi Acupuncture Needles	Dong Bang, U.S.A.	MQX	Class II	1997-10-17
K971233	Soft Tip Epidural Catheter Kit	B.Braun Medical, Inc.	CAZ	Class II	1997-10-17
K970864	Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters	Arrow Intl., Inc.	FOZ	Class II	1997-10-17
K973530	Infinty Distal Femoral Component	Wrightmedicaltechnologyinc	LPH	Class II	1997-10-16
K973526	Sunglasses	Pyramid Handbags, Inc.	HQY	Class I	1997-10-16
K973500	Bard Endoscopic Overtube (#000307)	C.R. Bard Inc	FED	Class II	1997-10-16
K973265	Verabond 2V	Aalba Dent, Inc.	EJH	Class II	1997-10-16
K973247	Vintage Halo	Shofu Dental Corp.	EIH	Class II	1997-10-16
K973067	Drts Remote Control Drape	Minrad, Inc.	JAA	Class II	1997-10-16
K973039	Legacy/legacy-D Table	GE Healthcare	IXR	Class II	1997-10-16
K973017	Synthes Combination Clamp and Dynamization Clip	Synthes (USA) Products LLC	KTT	Class II	1997-10-16
K972792	Duration Stabilized Uhmwpe Acetabular Components	Howmedica Corp.	JDI	Class II	1997-10-16
K972709	Tbi Stand	Mick Radio-Nuclear Instruments, Inc.	IYE	Class II	1997-10-16
K972229	Imageview Coronary Angiography Display and Review System	HeartWare, Inc.	IZI	Class II	1997-10-16
K972156	Quix Rapid E. Coli O157 Strip Test	Guardian Scientific, Corp.	GMZ	Class I	1997-10-16
K972143	Moa Bone / M-Sphere	Iop, Inc.	HPZ	Class II	1997-10-16
K971883	Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System	Synthes (USA) Products LLC	KWQ	Class II	1997-10-16
K971576	Rejoyn Penile Support System	American Medtech	LKY	Class II	1997-10-16
K971137	Bard Rapidfire Multiple Band Ligator	C.R. Bard Inc	MND	Class II	1997-10-16
K970741	Powerheart Aecd	ZOLL Medical Corporation	MKJ	Class III	1997-10-16
K970499	Branemark System Zygomaticus Fixture System	Nobel Biocare Uas, Inc.	DZE	Class II	1997-10-16
K964880	Vari-Angle Hip Screw (Vhs) System	Walter Abendschein, M.D.	KTT	Class II	1997-10-16
K964159	Cd Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1997-10-16
K963335	Harmac Balloon Wedge Pressure Catheter	Harmac Medical Products	DQO	Class II	1997-10-16
K962829	Harmac Balloon Angiographic Catheter	Harmac Medical Products	DQO	Class II	1997-10-16
K972973	Perception Inc. Gps-Tuv Diagnostic Ultrasound System	Perception, Inc.	IYO	Class II	1997-10-15
K972879	Ultrafast CT Scanner; Ebt CT Scanner, Evolution	Imatron, Inc.	JAK	Class II	1997-10-15
K972826	Esteem 1.5T MRI System	Elscint Mr, Inc.	LNH	Class II	1997-10-15
K972807	(Lenses)benz Hefilcon a Spherical/toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue or Light Green Visibi	Benz Research and Development LLC	LPL	Class II	1997-10-15
K972691	Abc Total Elbow Prothesis	Zimmer GmbH	JDB	Class II	1997-10-15
K972690	Zirconia Ceramic Femoral Head	Zimmer GmbH	LZO	Class II	1997-10-15
K962833	Harmac Temporary Pacing Catheter with Balloon	Harmac Medical Products	LDF	Class II	1997-10-15
K973791	Abc Calibration Verifiers	Sc Calibrators & Controls, LLC	JJY	Class I	1997-10-14
K973790	Abc Linearity Verifiers	Sc Calibrators & Controls, LLC	JJY	Class I	1997-10-14
K973376	Lori/lori, Lori-S (Lori Stock Aid)	Lori Medical Laboratories, Inc.	ESD	Class I	1997-10-14
K973175	Tongue Klean	Softek Ent.	LCN	Class I	1997-10-14
K972910	Pors on Lite	Degussa AG	EJT	Class II	1997-10-14
K972762	Cardiometrics Flowire 300 and Xt 300 Doppler Guide Wires	Cardio Metrics, Inc.	DQX	Class II	1997-10-14
K972686	Vcar Option to the Dst and Dst-Xl Gamma Cameras and Vision Powerstation Computer	Smv America	KPS	Class II	1997-10-14
K971501	Sleepscan Airflow Pressure Transducer	Bio-Logic Systems Corp.	MNR	Class II	1997-10-14
K970839	Servo Ventilator 300A	Siemens Elema AB	CBK	Class II	1997-10-14
K973557	Lubriglide	Qualis, Inc.	KMJ	Class I	1997-10-10
K973489	Loracarbef Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-10-10
K973488	Lomefloxacin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-10-10
K973157	Liquid Ggt (Gamma Glutamyl Transferase) Reagent Set	Horiba Instruments Incorporated	JQB	Class I	1997-10-10