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 1897 of 3531

510(k) clearances, page 1897 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963018	Bio-Rad Serum Proteins by Capillary Electrophoresis	Bio-Rad	CEF	Class I	1997-06-04
K971911	Lumax Cystometry Administration Tube Set	Greatbatch Medical	FEN	Class II	1997-06-03
K971788	Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron Cx Systems RF Calibrator	Beckman Instruments, Inc.	DHR	Class II	1997-06-03
K971606	Sterile Flexofile Files and Instruments	Dentsply Intl.	EFA	Class I	1997-06-03
K971539	Novatip Family of Laser Handpiece Tips	Xanova Corp.	GEX	Class II	1997-06-03
K971513	Compoglass F	Ivoclar North America, Inc.	EBF	Class II	1997-06-03
K971506	Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator	Beckman Instruments, Inc.	DMT	Class II	1997-06-03
K971411	Disposable Silicone Epistaxis Catheter V-27030/Disposable Silicone Epistaxis Catheter Kit V-27030K	Bentec Medical, Inc.	EMX	Class I	1997-06-03
K971284	Opaldam	Ultradent Products Inc.	EIG	Class I	1997-06-03
K971283	Synchron Systems Cal 5 Plus	Beckman Instruments, Inc.	JIX	Class II	1997-06-03
K971201	Auto Suture* Ilm** Kit	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1997-06-03
K971114	Bioaccess Marrow Harvest System	Bioaccess, Inc.	GDM	Class I	1997-06-03
K971063	Optima Plus E Dental Chair; a Dental Chair; Excel Chair	King Dental Corp.	KLC	Class I	1997-06-03
K971039	Hemagen Anti Cardiolipin Screen	Hemagen Diagnostics, Inc.	MID	Class II	1997-06-03
K971036	Odontit Autogenous Bone Collection Device	Interpore Intl.	GCY	Class I	1997-06-03
K970957	Osteonics Restoration Acetabular Ring	Osteonics Corp.	JDJ	Class II	1997-06-03
K970950	Easy Rod	Acromed Corp.	MNH	Class II	1997-06-03
K970823	Scimed 8 French Wiseguide Guide Catheter	Scimed Life Systems, Inc.	DQY	Class II	1997-06-03
K970804	Tru-Pulse CO2 Surgical Laser	Tissue Technologies, Inc.	GEX	Class II	1997-06-03
K970791	Innerwear/extrawear/jimmy-O Raincoat/zeus/gentlemen's Choice/jasmine/drink/naughty	Custom Services Intl., Inc.	LTZ	Class II	1997-06-03
K970775	Tempo Cem (Multiple)	Foremost Dental Mfg., Inc.	EMA	Class II	1997-06-03
K970774	Tempocem Ne (Multiple)	Foremost Dental Mfg., Inc.	EMA	Class II	1997-06-03
K970523	Solo	Ranger All Season Corp.	INI	Class II	1997-06-03
K970243	Cynosure Dls-10-810 Diode Laser General Photocoagulator	Cynosure, LLC	GEX	Class II	1997-06-03
K965204	Avanta Orthopaedics Trapezium Implant	Avanta Orthopaedics, Inc.	KYI	Class II	1997-06-03
K964549	Aloka Ust-5258-5 Diagnostic Ultrasound Transducer	Aloka Co., Ltd.	ITX	Class II	1997-06-03
K971833	Elecsys Ferritin	Boehringer Mannheim Corp.	JMG	Class II	1997-06-02
K971517	Silicone Putty Ear Plugs	Bentec Medical, Inc.	EWD	Unclassified	1997-06-02
K971085	Soft Tip Multi-Lumen Central Venous Catheter	B.Braun Medical, Inc.	LJS	Class II	1997-06-02
K970942	Model 1320, Neurolink II Neuromonitoring System	Physiometrix, Inc.	GWQ	Class II	1997-06-02
K970792	Innerwear/extrawear/jimmy-O Raincoat/zeus/gentlemen's Choice	Titan Condoms	HIS	Class II	1997-06-02
K970767	Condom (Rubber), Lubricated, Extra Strength	Custom Services Intl., Inc.	HIS	Class II	1997-06-02
K970446	Drake Willock System & Altra Touch 1000 Dialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1997-06-02
K964986	Quanta Lite Iga Gliadin Elisa	Inova Diagnostics, Inc.	MST	Class II	1997-06-02
K964929	Peripherally Inserted Central Catheter	B.Braun Medical, Inc.	LJS	Class II	1997-06-02
K964801	Optical Tracking System (Ots)	Radionics Software Applications, Inc.	HAW	Class II	1997-06-02
K963571	Vygon Multi-Dose Vial Adapter & Bionector	Vygon Corp.	FMI	Class II	1997-06-02
K971691	Liquichek Urine Toxicology Control - Level S1, S2, S3	Bio-Rad	DIF	Class I	1997-05-30
K971376	Dried Gram-Negative Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1997-05-30
K971218	Quikstrip One Step Amphetamine Test	Drial Consultants, Inc.	DKZ	Class II	1997-05-30
K970824	Mdx 2000, Digital Analyzer	Shotwell & Carr, Inc.	JOY	Class II	1997-05-30
K970491	Dupel II Buffered Iontophoresis Electrodes	Empi	EGJ	Class II	1997-05-30
K964985	Quanta Lite Igg Gliadin Elisa	Inova Diagnostics, Inc.	MST	Class II	1997-05-30
K964344	Igg Anti-Gliadin (Igg-Aga) Antibody Test Kit	Immco Diagnostics, Inc.	MST	Class II	1997-05-30
K964341	Iga Anti-Gliadin (Iga-Aga) Antibody Test Kit	Immco Diagnostics, Inc.	MST	Class II	1997-05-30
K951928	Double-Hole Pencile-Point Spinal Needle (Dhpp Spinal Needle)	Csen, Ltd.	BSP	Class II	1997-05-30
K951927	Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)	Csen, Ltd.	BSO	Class II	1997-05-30
K971748	Tas Pt-Nctest Controls	Cardiovascular Diagnostics, Inc.	GGN	Class II	1997-05-29
K971495	Pathfinder Sunglasses	Coil	HQY	Class I	1997-05-29
K971454	Tympanostomy Ventilation Tube	Ikonos Corp.	ETD	Class II	1997-05-29