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 2750 of 3530

510(k) clearances, page 2750 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880669	L-5 Plastic Surgery Cannulas	American Instrument Manufacturer'S, Inc.	GEA	Class I	1988-03-17
K880398	Power Toilet Elevator	Med-West, Inc.	INO	Class II	1988-03-17
K880373	Ionometer E-Hk and Accessories	Smash Ent., Inc.	GKF	Class II	1988-03-17
K880293	The Storz Bipolar Pencil and Cord	Storz Instrument Co.	GXI	Class II	1988-03-17
K880031	Pathfinder(tm) Direct Detection Sys C. Trachomatis	Kallestad Diag, A Div. of Erbamont, Inc.	LJP	Class I	1988-03-17
K880020	3 in 1 Automatic Tourniquet	Systematics Mfg. & Tool Co., Inc.	KCY	Class I	1988-03-17
K880007	Toxo Igm Test	Gull Laboratories, Inc.	GLZ	Class II	1988-03-17
K875237	Optec 1000 Dmv Vision Tester Modify	Stereo Optical Company LLC	HOX	Class I	1988-03-17
K880726	Jms Apheresis Needle	JMS Co., Ltd.	FIE	Class II	1988-03-16
K880662	Vision(r) Thyroxine (T4)	Abbott Medical	KLI	Class II	1988-03-16
K880630	Lactate Dehydrogenase (Ldh-L)	Tech-Co, Inc.	CFH	Class II	1988-03-16
K880617	Addition of Ampicillin/sulbactam & Ciprofloxacin	Pasco Laboratories, Inc.	JWY	Class II	1988-03-16
K880609	Analyte Carbon Dioxide Assayed on Technicon Ra(tm)	Technicon Instruments Corp.	KHS	Class II	1988-03-16
K880496	Lyphochek Quantitative Urine Control Normal (1)	Bio-Rad	JJW	Class I	1988-03-16
K880315	Dade Antithrombin III Chromogenic Assay	Baxter Healthcare Corporation	JBQ	Class II	1988-03-16
K880230	Sixalyzer	Lukens Corp.	IKK	Class II	1988-03-16
K874361	Biodynamics Model Bi-300 Body Composition Analyzer	Biodynamics Corp.	DSB	Class II	1988-03-16
K872059	Dripride Provide Ultra	Weyerhaeuser Co.	EYQ	Class I	1988-03-16
K871242	Reverse Osmosis Water Purification System	Medro Systems, Inc.	FIP	Class II	1988-03-16
K880912	Dynatron 2000	Dynatronics Corp.	IKE	Class I	1988-03-15
K880787	Easy-Test Lactic Acid (La)	Diagnostic Systems	KHP	Class I	1988-03-15
K880628	Triglycerides (Gpo-Trinder)	Tech-Co, Inc.	CDT	Class I	1988-03-15
K880577	Concep-7-Bhcg	Leeco Diagnostics, Inc.	JHI	Class II	1988-03-15
K880495	Lyphochek Quantitative Urine Control Abnormal (2)	Bio-Rad	JJW	Class I	1988-03-15
K880461	Perfecta Total Hip System	Orthomet, Inc.	JDI	Class II	1988-03-15
K880397	Direct Bilirubin Procedure Run on a Au5000 Instru.	Data Medical Associates, Inc.	CIG	Class II	1988-03-15
K880396	Total Bilirubin Procedure Run on a Au5000 Instru.	Data Medical Associates, Inc.	CIG	Class II	1988-03-15
K880395	Total Bilirubin Procedure Run on a Demand Instru.	Data Medical Associates, Inc.	CIG	Class II	1988-03-15
K880381	Telos Distal Targeting Device	Austin Assoc.	HXY	Class I	1988-03-15
K880328	Hcg-Nostick	bioMerieux, Inc.	JHJ	Class II	1988-03-15
K880307	Alkaline Phosphatase Reagent Set	Tech-Neal Scientific, Inc.	CJE	Class II	1988-03-15
K880268	CO2 Reagent	Sigma Diagnostics, Inc.	KHS	Class II	1988-03-15
K880263	Osi Rizzoli Orthopedic Table/manual Version	Mizuho Orthopedic Systems Inc	JEB	Class I	1988-03-15
K880242	Kone Calcium Test	The Rupp & Bowman Co.	CJY	Class II	1988-03-15
K880238	Triglyceride	Tech-Neal Scientific, Inc.	CDT	Class I	1988-03-15
K880236	Glucose Hexokinase	Tech-Neal Scientific, Inc.	CFR	Class II	1988-03-15
K880100	Cook Urological Wire Guide W/hydromer Coating	Cook Incorporated	KOD	Class II	1988-03-15
K880090	Ion Trap Detector	Finnigan Corp.	DOP	Class I	1988-03-15
K880081	Vision Care/phakosystems Echopach	Phakosystems, Inc.	IYO	Class II	1988-03-15
K880065	Nidek Up-2000	Nidek, Inc.	IYO	Class II	1988-03-15
K873939	Adi/b/*/ha-2 Stage Osseo. Hydro. Dental Implant	Anchor Implants, Ltd.	DZE	Class II	1988-03-15
K880986	Mechanical Walker	Canhart Industries, Inc.	INM	Class I	1988-03-14
K880895	Uresil Wound Drain Trocar	Uresil, LLC	GBS	Class I	1988-03-14
K880826	Microloc(tm) Porous Coated Unicondylar Knee System	Johnson & Johnson Professionals, Inc.	KYK	Class II	1988-03-14
K880800	Golden Power Lift Chair	Golden Technologies, Inc	INO	Class II	1988-03-14
K880786	Bushline Care Chair	Bushline Corp.	INO	Class II	1988-03-14
K880737	Self Guiding (Sg) Interlocking Nail	Orthopaedic Designs, Inc.	HSB	Class II	1988-03-14
K880273	Widex Hearing Aid Model C1	Widex Hearing Aid Co., Inc.	ESD	Class I	1988-03-14
K880223	Magic Ear Model Mb Behind-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1988-03-14
K880195	Gynescope	Medgyn Products, Inc.	HEX	Class II	1988-03-14