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 2065 of 3531

510(k) clearances, page 2065 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945188	Cemax Vipstation And/or Software	Cemax, Inc.	LLZ	Class II	1995-08-02
K944975	Magnetic Hdl Cholesterol Test	Reference Diagnostics, Inc.	LBR	Class I	1995-08-02
K944051	Absorbalbe Anchor	Mitek Surgical Products, Inc.	MNV	Class II	1995-08-02
K943654	Harvey Chemiclave Ec5000, Ec5500, Ec6000 Sterilizers	Mdt Biologic Co.	MLR	Class II	1995-08-02
K953207	Human C-Reactive Protein Kit (Modification)	The Binding Site	DCK	Class II	1995-08-01
K952817	Bio-Rad Urinary 5-Hiaa by Hplc	Bio-Rad	CDA	Class I	1995-08-01
K951961	Ksea Model 26012Ch Electronic Laparoflator	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1995-08-01
K951636	Imx Toxo Igg	Abbott Medical	LGD	Class II	1995-08-01
K951611	Imz - Dental Implant Single Tooth Attachment	Imz, GmbH	DZE	Class II	1995-08-01
K951609	Imz - Dental Implant Surgical Tray	Imz, GmbH	DZE	Class II	1995-08-01
K950429	Video Sigmoidoscope	Welch Allyn Inc	FAM	Class II	1995-08-01
K944417	Zeua Mycoplasma	Zeus Scientific LLC	GRZ	Class I	1995-08-01
K953429	Champion, 1000	Kuschall of America	IOR	Class I	1995-07-31
K953428	Champion, 3000	Kuschall of America	IOR	Class I	1995-07-31
K953427	Champion, 3000 Rebel	Kuschall of America	IOR	Class I	1995-07-31
K953426	Competitor	Kuschall of America	IOR	Class I	1995-07-31
K953212	C-Reactive Protein Immunoturbidimetric Kit & Crp Calibrator	Randox Laboratories, Limited	DCK	Class II	1995-07-31
K953197	Ektachem Clinical Chemistry Slide C-Reactive Protein (Crp)	Johnson & Johnson Clinical Diagnostics, Inc.	DCK	Class II	1995-07-31
K952926	Questus Disposable Endoscopic Knife	Wrightmedicaltechnologyinc	GCJ	Class II	1995-07-31
K952861	Angiocath & Insyte Autoguard Catheters	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1995-07-31
K952842	Endopath* Tristar Flat Bladed Surgical Obturator & Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1995-07-31
K952757	Angiocath, Novbalon, Angio-Set Intravascular & Angiocath Introduction Drainage Catheter	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1995-07-31
K952754	Sacs, Independent Fiber Coolant System	Surgical Laser Technologies, Inc.	GEX	Class II	1995-07-31
K952733	Sidefire - Tipped Reusable Optical Fibers	Myriad Lase, Inc.	GEX	Class II	1995-07-31
K952691	Welch Allyn Premium Lightweight Headlight	Welch Allyn Inc	FJC	Class II	1995-07-31
K952640	Cannulated Plus Hip Screw	Wrightmedicaltechnologyinc	JDW	Class II	1995-07-31
K952636	Medlite Laser System	Continuum Biomedical, Inc.	GEX	Class II	1995-07-31
K952609	Redi Drill Drill System	Trebay Medical Corp.	EQJ	Class I	1995-07-31
K952555	Cobas-Fp Application for Free Phenytoin, Cobas-Fp Phenytoin Calibrators, & Controls	Roche Diagnostic Systems, Inc.	MOJ	Class II	1995-07-31
K952325	Et Tube Placement Detector (with Colibri Indicator)	Icor AB	CCK	Class II	1995-07-31
K952272	Ti. Alloy 2.0 Mm Cortex Screw	Synthes (USA) Products LLC	HWC	Class II	1995-07-31
K952258	Hurricane	Hurricane Hardware, Inc.	HQY	Class I	1995-07-31
K952256	Picc Line Kit	Medi-Flex Hospital Products, Inc.	FOZ	Class II	1995-07-31
K952234	Barrier All Film	Cottrell, Ltd.	EFS	Class I	1995-07-31
K952203	Otosilk	Boston Medical Products, Inc.	NAD	Class I	1995-07-31
K952196	IV Pole/stand	Valentine Intl. Ltd.	FOX	Class I	1995-07-31
K952103	Aeros Aspirator	Aeros Instruments, Inc.	BTA	Class II	1995-07-31
K951901	Masterscreen Pft Body	Erich Jaeger GmbH & Co. KG	JEH	Class II	1995-07-31
K951325	Comfeel Plus Pressure Relief Dressing	Richard Hamer Assoc., Inc.	FMP	Class I	1995-07-31
K951268	Spine-Tech Modified Laparoscopic Spinal Fusion Instrument System	Spine-Tech, Inc.	HRX	Class II	1995-07-31
K951078	Catheter, Intravascular or Percutaneous	Sims Deltec, Inc.	LJS	Class II	1995-07-31
K951077	Vital-Port Petiet Polysulfone Vascular Access System	Med Institute, Inc.	LJT	Class II	1995-07-31
K950864	Gts Great Toe System - (Metatarsal Component with Porous Coating)	Acu Med, Inc.	LZJ	Unclassified	1995-07-31
K945948	Absogel Sterile Powder-Free Surgical Gloves	Ampri Rubberware Industries Sdn Bhd	KGO	Class I	1995-07-31
K944276	Sloan Sta-Dri Bootleg Legging	Sloan Corp.	LYU	Class I	1995-07-31
K944118	Sloan Sta-Dri Surgical Jumpsuit	Sloan Corp.	LYU	Class I	1995-07-31
K943433	Total Contact Seat Ripple System	Numotech, Inc.	IOQ	Class II	1995-07-31
K943249	Bioabsorbable Interference Screw	Instrument Makar, Inc.	MAI	Class II	1995-07-31
K953314	Conceptus Fallopian Tube Catheterization System	Conceptus, Inc.	MOV	Class II	1995-07-28
K953096	Essential Shaver System	Smith & Nephew Richards, Inc.	EQJ	Class I	1995-07-28