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 2026-11-02, 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 2402 of 3531

510(k) clearances, page 2402 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915214	Arthroscopy Camera Drape	O.R. Concepts, Inc.	KKX	Class II	1992-01-09
K915152	Rangeroller	Excel Mobility Products, Inc.	ITI	Class II	1992-01-09
K915150	Remove Adhesive Remover	Smith & Nephew United, Inc.	KOX	Class I	1992-01-09
K915141	712 Plastic Surgery Table & Accesories	Midmark Corp	FQO	Class I	1992-01-09
K915076	Med-Equip Corporation	Medequip Co.	ESD	Class I	1992-01-09
K914972	Carpentier-Edwards(r) Flex Annul Ring, 4500 Tricus	Baxter Healthcare Corporation	KRH	Class II	1992-01-09
K914919	Smith & Nephew Dyonics Laparoscopy System	Smith & Nephew Dyonics, Inc.	GCJ	Class II	1992-01-09
K914899	Sonotone Behind the Ear Model St 45G	Sonotone Hearing Instruments	ESD	Class I	1992-01-09
K914898	Sonotone Behind the Ear Model St 47I	Sonotone Hearing Instruments	ESD	Class I	1992-01-09
K914820	Dsl Insulin Ria (Dsl 1600)	Diagnostic Systems Laboratories, Inc.	CFP	Class I	1992-01-09
K914812	K-Cap-E, Sterile	Westcon Orthopedics, Inc.	LYT	Class II	1992-01-09
K914811	Il Test(tm) Hdl Cholesterol	Instrumentation Laboratory Co.	LBR	Class I	1992-01-09
K914608	Breast Les Local Wire St. 48219/49220/48119/48120	Dlp, Inc.	GAA	Class I	1992-01-09
K914280	Echosight Stent Set	Cook Incorporated	FAD	Class II	1992-01-09
K914255	Liquichek(r) Unassayed Chemistry Contr(human) 1&2	Bio-Rad	JJY	Class I	1992-01-09
K914201	Lm- Lap 10 High Flow Insufflator	Leisegang Medical, Inc.	HIF	Class II	1992-01-09
K914026	Angiodynamics Angiofill Fluid Management System	E-Z-EM, Inc	FPA	Class II	1992-01-09
K913972	Star Sync, Modification	Infrasonics Corp.	CBK	Class II	1992-01-09
K913751	Pressure Infuser	Biomedical Dynamics, Inc.	KZD	Class I	1992-01-09
K913077	Lancaster Cooling Jacket, Cat. Code #13500/13501	Dlp, Inc.	DTR	Class II	1992-01-09
K912890	Model Sonicaid Axis	Oxford Medilog, Inc.	HGM	Class II	1992-01-09
K912819	Sc1150 Cw/pd	Pie Medical Equipment B.V.	IYN	Class II	1992-01-09
K912776	Cardiometrics Flowire/flomap Doppler Ultrasound	Cardio Metrics, Inc.	ITX	Class II	1992-01-09
K912562	Abcom 2000	Applied Biometrics, Inc.	DPW	Class II	1992-01-09
K912001	Convertray, Modification	Wilde Dental (USA)	ELW	Class II	1992-01-09
K911915	Hemoclip II	Edward Weck, Inc.	FZP	Class II	1992-01-09
K915441	Marathon 13K/h Microhematocrit Centrifuge	Fisher Scientific Company L.L.C.	GKF	Class II	1992-01-08
K915213	Corvac Blood Collection Tube	Sherwood Medical Co.	GIM	Class II	1992-01-08
K915087	Dmi Blod Gas Analyzer/cartridge	Diamond Medical, Inc.	CHL	Class II	1992-01-08
K914901	Vacutainer Kit	Abbott Medical	GIM	Class II	1992-01-08
K914860	Sutter Model 10000 Leg Cpm Device	Sutter Corp.	BXB	Class I	1992-01-08
K914828	010 Hi-Tor Inter/stand Guidwire Preshape Tip/modif	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1992-01-08
K914769	Extendo-Bac Table	Reinert Technics, Inc.	INW	Class I	1992-01-08
K914543	St5500 Universal Care Stretcher	Lic Care, Inc.	FPO	Class II	1992-01-08
K913998	Pam Plus	KCI USA, Inc.	IRO	Class I	1992-01-08
K913339	Horizon Pacemaker Detection Software	Mennen Medical, Inc.	DSI	Class II	1992-01-08
K912734	Interpore Hex Head Implant Restorative Components	Interpore Intl.	DZE	Class II	1992-01-08
K911615	Holter 24-Hour ECG System, Model Number: Dms 300	Diagnostic Monitoring Software	DQK	Class II	1992-01-08
K915482	B-D Ultra-Vue Procedure Needle W/ Westcott Type Pt	BD Becton Dickinson Vacutainer Systems Preanalytic	DWD	Class II	1992-01-07
K915481	B-D Ultra-Vue Procedure Needle W/ Chiba Type Point	BD Becton Dickinson Vacutainer Systems Preanalytic	DWD	Class II	1992-01-07
K915480	B-D Ultra-Vue Procedure Needle W/ Spinal Type Pt.	BD Becton Dickinson Vacutainer Systems Preanalytic	DWD	Class II	1992-01-07
K915427	Ors-1000	Mnlase, Inc.	JRM	Class I	1992-01-07
K914997	Asp-Irrator	Conmedcorp	GCJ	Class II	1992-01-07
K914891	Puller Option for Etude(tm)	Dantec Medical, Inc.	FAP	Class II	1992-01-07
K914882	Wiltek Balloon Cholangiography Catheter	Wiltek Medical, Inc.	FGE	Class II	1992-01-07
K914881	Wiltek Laparoscopic Cholangiography Catheter	Wiltek Medical, Inc.	FGE	Class II	1992-01-07
K914805	Tc-1000, Tc-1050 System	Gaymar Industries, Inc.	DWJ	Class II	1992-01-07
K914732	Core Medical Biopsy Needle	Core Medical, Inc.	FCG	Class II	1992-01-07
K914516	9 French Lithotripter Electrode, Modification	Northgate Technologies Inc.	FFK	Class II	1992-01-07
K914515	3 French Lithotripter Electrode, Modification	Northgate Technologies Inc.	FFK	Class II	1992-01-07