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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2757 of 3530

510(k) clearances, page 2757 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880266	Multi-Enzyme Linearity Solution	Verichem Laboratories, Inc.	JJT	Class I	1988-02-18
K880265	Wehbe Arm Holder	Mizuho Orthopedic Systems Inc	FWZ	Class I	1988-02-18
K880227	Arthrobot(tm) Lower Limb Positioner	Andronic Devices, Ltd.	FQO	Class I	1988-02-18
K880215	Tsrh H/m Hook, Eyebolt/lock Nut Assem., Spinal Rod	Warsaw Orthopedic, Inc.	KWP	Class II	1988-02-18
K880214	Tsrh H/m Torque Limiting Wrench	Warsaw Orthopedic, Inc.	KWP	Class II	1988-02-18
K880178	Creatine Kinase (Colorimetric Method)	Tech-Co, Inc.	JHY	Class II	1988-02-18
K880176	Hdl Cholesterol Precipitating Reagent	Tech-Co, Inc.	LBR	Class I	1988-02-18
K880166	Bovie Ultrasonic Surgical Aspirator, Model Me2000	Clinical Technology Inc.	LFL	Unclassified	1988-02-18
K880151	Hip, Femur and Humerus Retractor	Twenty-First Century Orthopedics, Inc.	GAD	Class I	1988-02-18
K880004	Townley Cox Comb Acetabular Cup	Orthomet, Inc.	JDI	Class II	1988-02-18
K875326	Modified Schneider-Shiley Flushing Catheter	Schneider-Shilley (USA)	DQO	Class II	1988-02-18
K875325	Modified Occluder/flushing Catheter Stopcock	Schneider-Shilley (USA)	DQO	Class II	1988-02-18
K875272	Sonoline Cf	Siemens Medical Laboratories, Inc.	DXK	Class II	1988-02-18
K875199	Np Bipolar Endocardial Lead W/vs-1 Connector	Biotronik Sales, Inc.	DTB	Class III	1988-02-18
K875153	Thieler Kit	Taris Corp.	KKX	Class II	1988-02-18
K875129	Steri-Clens	Absorbent Cotton Co., Inc.	GEC	Class I	1988-02-18
K875071	Aspartate Aminotransferase Ast/sgot	Tech-Co, Inc.	CIT	Class II	1988-02-18
K875048	Sarns Venoatrial Catheter	3M Health Care, Sarns	DWF	Class II	1988-02-18
K874948	Sun Medical Smoke Evacuator System	Sun Medical Co., Ltd.	GEX	Class II	1988-02-18
K874899	Canyon Medical Femoral Bypass Cannulae	Canyon Medical Products	DWF	Class II	1988-02-18
K874882	Acromed Cross Rod Connector	Acromed Corp.	KWP	Class II	1988-02-18
K874874	Acs Hi-Torque Coronary Guiding Catheter W/soft Tip	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1988-02-18
K874808	Coat-a-Count Opiates Screen Tkos1, Tkos5	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1988-02-18
K874763	Cellect Model D, Automated Hemtalogy Analyzer	Instrumentation Laboratory Co.	GKZ	Class II	1988-02-18
K874731	Lyphochek Whole Blood Control	Bio-Rad	JJY	Class I	1988-02-18
K874727	Precept(tm) Ciprofloxacin	Austin Biological Laboratories	JWY	Class II	1988-02-18
K874500	Glass Ionomers-Bio-Glass Base/lining & Luting Cem.	Harry J. Bosworth Co.	EMA	Class II	1988-02-18
K874442	Dinamap Vital Signs Monitor/pulse Oximeter	Critikon Company, LLC	DQA	Class II	1988-02-18
K874362	Amerlite T3u Assay Lan.0004/1004/2004, 240/480/144	Amersham Corp.	KHQ	Class II	1988-02-18
K873762	Series 77000 Ultrasound Imaging System	Hewlett-Packard Co.	DXK	Class II	1988-02-18
K873550	Dsl Active Estradiol Ria (Dsl #4300)	Diagnostic Systems Laboratories, Inc.	CHP	Class I	1988-02-18
K873032	Genesis II, 2.5/5.0 Mhz S.e/5.0mhz/3.5 16/19 Mm an	Biosound, Inc.	DXK	Class II	1988-02-18
K872632	Du Pont Herpchek Hsv Antigen Elisa Test Kit	E.I. Dupont de Nemours & Co., Inc.	GQN	Class II	1988-02-18
K871912	Pv-Lab, Model Pvl-1, Peripheral Vascular System	Electro-Diagnostic Instruments	DPT	Class II	1988-02-18
K871852	Coxa Acetabular Cup	Thackray USA	JDI	Class II	1988-02-18
K880399	V-Trend Im Dry-Spot Test	Texas Immunology, Inc.	KTN	Class II	1988-02-17
K880341	N-Immunoglobulin Light Chain Kit	Behring Diagnostics, Inc.	DFH	Class II	1988-02-17
K880324	Micro-Aire Cement Removal Tools	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1988-02-17
K880156	Volz Total Wrist Prosthesis	Zimmer GmbH	KWM	Class II	1988-02-17
K880045	Acromed Awl/punch, Depth Gauge	Buckman Co., Inc.	HWJ	Class I	1988-02-17
K880002	Multi-Allergen Ige Fast Screen (Molds)	3M Company	DHB	Class II	1988-02-17
K875360	The Beltone 2000 Audiometer	Beltone Electronics Corp.	EWO	Class II	1988-02-17
K875354	Unistep Capillary Blood Collection System	Ulster Scientific, Inc.	LCP	Class II	1988-02-17
K875315	i.v. Start Kits	Ni-Med, Inc.	LRS	Class II	1988-02-17
K875282	Qm300 Calibrator B Pack	Kallestad Diag, A Div. of Erbamont, Inc.	JIX	Class II	1988-02-17
K875274	Total Ige Immuno Response Test (Irt(r))	Incstar Corp.	DHB	Class II	1988-02-17
K875254	Gullsorb Igg Inactivation Reagent	Gull Laboratories, Inc.	DEW	Class II	1988-02-17
K875223	Danninger Orthopaedic Awl	Danninger Medical Technology, Inc.	HWJ	Class I	1988-02-17
K875201	Plus Total Knee System, Poly Tibial Peg	Orthomet, Inc.	JWH	Class II	1988-02-17
K875161	Mat (Tm) Microalbumin Test	Wampole Laboratories	DCF	Class II	1988-02-17