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 2141 of 3531

510(k) clearances, page 2141 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942823	Mahe Instruments	Mahe Intl., Inc.	DWG	Class II	1994-12-05
K942704	Card Guard, Model Cg-7000D ECG Recorder/transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	1994-12-05
K942565	Altair-Disc Recorder	Burdick Corp.	DQK	Class II	1994-12-05
K942442	Acufex T-Fix Delivery System	Acufex Microsurgical, Inc.	MIA	Class II	1994-12-05
K942341	Cannulated Cancellous Bone Screw	Acu Med, Inc.	HWC	Class II	1994-12-05
K942340	Cortical Bone Screw	Acu Med, Inc.	HWC	Class II	1994-12-05
K941367	Webb-Morley Spine System	Electro-Biology, Inc.	KWQ	Class II	1994-12-05
K940012	Smartbrace Electrode	Medical Devices Inc.	GXY	Class II	1994-12-05
K935846	Model Acuity Central Station	Protocol Systems, Inc.	DSI	Class II	1994-12-05
K935377	R and D Batteries	R & D Batteries, Inc.	HGM	Class II	1994-12-05
K935301	R & D Batteries, Inc. Part Numbers 5235, 5506 & 5050	R & D Batteries, Inc.	HGM	Class II	1994-12-05
K933461	Boehringer Mannheim Bicarbonate Assay	Boehringer Mannheim Corp.	KHS	Class II	1994-12-05
K924646	Over the Guidewire Dilatation System	Medovations, Inc.	KNQ	Class II	1994-12-05
K911820	Ged (Graduated Electronic Decelerator	Behavior Research Institute, Inc.	HCB	Class II	1994-12-05
K945368	Phosphorus Test (Phos)	EMD Millipore Corporation	CEO	Class I	1994-12-02
K945288	Inhealth Blom-Singer Indwelling Plug Insert Accessory Device	Freudenberg Medical, LLC	EWL	Class II	1994-12-02
K945197	The Sharps Collection and Disposal System	Devon Industries, Inc.	MMK	Class II	1994-12-02
K944981	3M Tempcare Light Cure Temporary System	3M Company	EBG	Class II	1994-12-02
K944953	Orex Medical Bedding	Thantex Specialties, Inc.	KME	Class I	1994-12-02
K944702	Procera All-Ceramic Porcelain	Nobelpharma USA, Inc.	EIH	Class II	1994-12-02
K944581	Cutinova Thin Wound Dressing	Beiersdorf, Inc.	KMF	Class I	1994-12-02
K944532	Prima, Inc. Ventilator Hoses	Prima, Inc.	BZA	Class I	1994-12-02
K944531	Prima, Inc. Corrugated Tubing	Prima, Inc.	BZO	Class I	1994-12-02
K944513	Linical Protein VI Calibration Verifiers Levels a-E	International Enzymes, Inc.	JJY	Class I	1994-12-02
K944486	Linical Protein I Calibration Verifiers Levels a - E	International Enzymes, Inc.	JJY	Class I	1994-12-02
K944452	Quantitate Electrolyte Verifier Set (Urine Range)	Beckman Instruments, Inc.	JJY	Class I	1994-12-02
K944303	Cook Urological Laparoscopic Trocar Cleaner	Cook Incorporated	GCJ	Class II	1994-12-02
K944231	Ontrak Testcup Collection/urinalysis Panel for Cocaine, Morphine and Thc	Roche Diagnostic Systems, Inc.	DIO	Class II	1994-12-02
K944114	Phlebotomy Unit Sharps a Gator	Devon Industries, Inc.	FMI	Class II	1994-12-02
K944074	Cx(tm) Methadone(metd) Reagent for Synchron Cx Syst	Beckman Instruments, Inc.	DJR	Class II	1994-12-02
K943892	Point of Use Sharps a Gator	Devon Industries, Inc.	FMI	Class II	1994-12-02
K943543	Medical Optics CO2 Surgical Laser Systems	Medical Options, Inc.	GEX	Class II	1994-12-02
K943510	Dried Gram-Positive Mic/combo Panels	Baxter Diagnostics, Inc.	JWY	Class II	1994-12-02
K943291	Anti Ds-DNA	Sigma Diagnostics, Inc.	LLL	Class II	1994-12-02
K943029	Iron Qvet	Prisma Systems	JIY	Class I	1994-12-02
K943002	Uric Acid Qvet	Prisma Systems	KNK	Class I	1994-12-02
K942999	Bilirubin(total) Qvet	Prisma Systems	CIG	Class II	1994-12-02
K942875	Model #900To3500 Head/neck Coil	Medic, Inc.	LNH	Class II	1994-12-02
K942873	Model #700To3500 Neck/abdominal Coil	Medic, Inc.	LNH	Class II	1994-12-02
K942847	Cobas(r)-Fp Reagent for Procainamide/calibrator	Roche Diagnostic Systems, Inc.	LAR	Class II	1994-12-02
K942179	Pro-Tec Disposable Sharps Containers	Pro-Tec Containers, Inc.	FMI	Class II	1994-12-02
K941748	Steri-Vac Gas Sterilizer Model 8Xl	3M Company	FLF	Class II	1994-12-02
K935371	R2 Pads, R2 Cath Pads, R2 Pace Pads, R2 Dispersive Pad	R2 Medical Systems	DRX	Class II	1994-12-02
K935169	Aptt-Es	Helena Laboratories, Corp.	GFO	Class II	1994-12-02
K934340	Biosite Diagnostics - Triage Panel for Drugs of Abuse Plus Tricyclic Antidepressants	Biosite Incorporated	LFI	Class II	1994-12-02
K931445	Ktp/532, Ktp/yag and Ktp/yag Xp	Laser Surgical Systems	GEX	Class II	1994-12-02
K945200	Fixodent, Fixodent Fresh, Fasteeth and Extra Hold Fasteeth Denture Adhesivces	Procter & Gamble Co.	KOO	Class I	1994-11-30
K945077	Instrument,filling,plastic,dental	Worldwide Dental, Inc.	EKJ	Class I	1994-11-30
K944987	Uro - Elite Table Accessories	Philips North America LLC	IXR	Class II	1994-11-30
K944945	Pulpdent Calcium Hydroxide Preparations	Pulpdent Corporation	EJK	Class II	1994-11-30