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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2898 of 3529

510(k) clearances, page 2898 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861889	D'ala Rapid Test	Pro-Lab, Inc.	JTO	Class I	1986-06-03
K861888	Hippurate Hydrolysis Test	Pro-Lab, Inc.	JTO	Class I	1986-06-03
K861575	Directatex Strep a	Pacific Biotech, Inc.	GTY	Class I	1986-06-03
K861986	Lido Back	Loredan Biomedical, Inc.	IKK	Class II	1986-06-02
K861921	Laser Bronchoscope System	Pilling Co.	LLO	Class II	1986-06-02
K861803	Brushing	Beaute Naturelle International, Inc.			1986-06-02
K861748	Ruby & Sapphire Blade Holder	Keeler Instruments, Inc.	HNN	Class I	1986-06-02
K861683	Monsanto Santoprene (Peritone Device)	Peritone Research, Ltd.	HIR	Class II	1986-06-02
K861643	Stylekeeper Contact Lens Carrying Case	Allergan	HPX	Unclassified	1986-06-02
K861626	Churchill Extension Tube	Churchill Corp.	FPK	Class II	1986-06-02
K861597	Behing-the-Ear Hearing Aid Series Sp	Maico Hearing Instruments, Inc.	ESD	Class I	1986-06-02
K861327	Roho Heel Pad	ROHO, Inc.	KIC	Class I	1986-06-02
K861277	Critichem Continuous Blood Gas Montitor, Cvgm-1000	Critichem, Inc.	DRY	Class II	1986-06-02
K861275	High Flow i.v. Set	Simplivia Healthcare Ltd.	FPA	Class II	1986-06-02
K861226	Interface Crystalloid Cardioplegic Filter Model 70	Medical, Inc.	KRJ	Class II	1986-06-02
K861091	Easistim	Promed Corp.	KOI	Class II	1986-06-02
K860957	Disposable Accessories for I/a Sys. & Viteous Cut.	Medical Corp. of America	HQC	Class II	1986-06-02
K860956	Kansas I/a System & Kansas I/a & Vitrectromy Syst.	Medical Corp. of America	HQC	Class II	1986-06-02
K860616	Volume Control Set with Extension	Med Fusion Systems, Inc.	FPA	Class II	1986-06-02
K860233	5 Mhz Intracavitary Probe, Model H4222v	General Electric Co.	HEM	Class II	1986-06-02
K860121	Intravascular Catheter W/doppler Transducer	Numed Inc	DPT	Class II	1986-06-02
K854942	Horizon 2000 Non-Invasive Blood Pressure Cap.	Mennen Medical, Inc.	DXN	Class II	1986-06-02
K854903	Gordon Diagnostic System Model I	Clinical Diagnostics, Inc.	LQD	Unclassified	1986-06-02
K854856	Thermorite Model Hc-83 Hypo/hyperthermia Unit	Thermorite, Inc.	DWJ	Class II	1986-06-02
K853953	Cardiocap Monitor	Instrumentarium Corp.	DRT	Class II	1986-06-02
K861971	Xomed Audiant Bone Conductor W/improved Aa Coil	Xomed, Inc.	LXB	Class II	1986-05-30
K861943	Pci Custom Design Series	Poston & Cole Intl.	IQC	Class II	1986-05-30
K861923	Sterile Disposable Suction Tube Catheter	Pilling Co.			1986-05-30
K861915	Surgical Head Support	Treace Medical, Inc.	CCX	Class I	1986-05-30
K861877	Byron Word Bartholian Gland Catheter	Byron Medical	GBA	Class I	1986-05-30
K861876	Cranio Blades and Wire Pass Drill	New England Surgical Instrument Corp.	GFA	Class I	1986-05-30
K861859	Cabot Videoscope	Cabot Medical Corp.	HRX	Class II	1986-05-30
K861765	Acs Wholey Hi-Torque Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-05-30
K861571	Type 6500 Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1986-05-30
K861530	Surgical Packs, Kits and Trays	Medical Concepts Development, Inc.	FSM	Class I	1986-05-30
K861455	Model Dt-102 Data Telephone Transmitter	Advantage Medical Systems, Inc.	HGM	Class II	1986-05-30
K861441	Neutralon Surgical Gloves	Surgikos, Inc.	KGO	Class I	1986-05-30
K861322	Rmi Porous Vent Plug	Research Medical, Inc.	DWF	Class II	1986-05-30
K861310	Stockert-Shiley Aortic Root Cannulae	Shiley, Inc.	DWF	Class II	1986-05-30
K861261	Ohmeda Posi-Pulse Suction Unit	GE Healthcare	GCX	Class II	1986-05-30
K861248	Curapuls 419 Diathermy Unit	Henley Intl.	IMJ	Class II	1986-05-30
K861247	Curamed 402 Diathermy Unit	Henley Intl.	IMJ	Class II	1986-05-30
K861041	Enhance	Packaging Technologies, Inc.	LYC	Class II	1986-05-30
K860619	Es 180-Dcm Muscle Stimulator	Promatek	IPF	Class II	1986-05-30
K860487	Urenamel, Posterior Restorative Material	Cadco Dental Products, Inc.	EBF	Class II	1986-05-30
K860372	Fast Flow Xx (Aqueous Solution Filter)	Healthtek, Inc.	FPB	Class II	1986-05-30
K860076	Gambro Ultrasonic Blood Level Detector Uld 10-200	Gambro, Inc.	DTW	Class II	1986-05-30
K854333	Biochem 515 Respiration Monitor	Biochem International, Inc.	BZQ	Class II	1986-05-30
K861940	Radiographic Tables Models A71os-T,a71ot-T,a71ob-T	D&R X-Ray Products, Inc.	IZZ	Class II	1986-05-29
K861887	Mem Glasgow Powdered Medium	Hazleton Research Products, Inc.	KIT	Class I	1986-05-29