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 2847 of 3529

510(k) clearances, page 2847 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861979	Aml II Titanium Acetabulum Prosthesis	Depuy, Inc.	JDI	Class II	1987-01-15
K870036	Bayer Healthcare Rapidqc Plus	Ciba Corning Diagnostics Corp.	JJS	Class I	1987-01-14
K864868	Microporous Monitoring Electrodes & Adapter Block	Hewlett-Packard Co.	DRX	Class II	1987-01-14
K864636	Erypur B	bioMerieux, Inc.	CAK	Class II	1987-01-14
K864623	Obstetrical/gynecological Custom Surgical Kit	Xanmed Corp.	KNA	Class II	1987-01-14
K864383	Luxtec, Killian and Vienna Nasal Speculums	Luxtec Corp.	EQH	Class I	1987-01-14
K864382	Frazier Suction Tube	Luxtec Corp.	EQH	Class I	1987-01-14
K864194	Palmer Obstetric Brace	AD-Tech Medical Instrument Corp.	KNC	Class II	1987-01-14
K864190	E-Z Hold - #4060	John F. Greer Co., Inc.	KMK	Class I	1987-01-14
K863842	Seralyzer Aris Carbamazepine Strips/modu/cali/cont	Miles Laboratories, Inc.	KLT	Class II	1987-01-14
K863532	Modified Labeling to Model 2000 Ambulatory Infuser	Parker Hannifin Corp.	FRN	Class II	1987-01-14
K863341	Cards(tm) - Early Pregnancy Test	Pacific Biotech, Inc.	LCX	Class II	1987-01-14
K863219	System 90 Transport	Datascope Corp.	DSP	Class II	1987-01-14
K863132	Digital Fluoricon Cardiac/vascular Quantitative	General Electric Co.	LLZ	Class II	1987-01-14
K863042	Sirecust 888/888R Non-Invasive Blood Press Monitor	Siemens Medical Solutions USA, Inc.	DSK	Class II	1987-01-14
K862483	Pantex Fte Free Testosterone Radioimmunoassay Kit	Pantex, Div. Bio-Analysis, Inc.	CDZ	Class I	1987-01-14
K862294	The Image/r	Quantum Diagnostics, Ltd.	LLZ	Class II	1987-01-14
K865102	Immpulse Coated Tube Phenytoin Assay Reagents	Sclavo, Inc.	LES	Class II	1987-01-13
K865075	H-H Subgaleal Trocar	Holter-Hausner Intl.	GYK	Class I	1987-01-13
K864905	Alkaline Phosphatase	Tech-Co, Inc.	CJE	Class II	1987-01-13
K864863	Dynalume(tm) Removawell Strips (No. 011-010-7403)	Dynatech Laboratories, Inc.	JKA	Class II	1987-01-13
K864744	Creatine Phosphokinase (Ck)	Tech-Co, Inc.	CGS	Class II	1987-01-13
K864743	Biuret (Colorimetric), Total Protein	Tech-Co, Inc.	CEK	Class II	1987-01-13
K864742	Urea Nitrogen(bun), Colorimetric Method	Tech-Co, Inc.	CDL	Class II	1987-01-13
K864635	Four Tank Dissolution Module	National Medical Care, Medical Products Div., Inc.	FKQ	Class II	1987-01-13
K864612	Dart Phenobarbital Assay System	Coulter Electronics, Inc.	LFN	Class II	1987-01-13
K864385	Luxtec Light Sources	Luxtec Corp.	FCW	Class II	1987-01-13
K864206	Reveal Colour Strep a Zl16	Wellcome Diagnostics	GTZ	Class I	1987-01-13
K864201	Lad Model 535 Luminometer	Los Alamos Diagnostics	JJQ	Class I	1987-01-13
K863175	Ees 10 Electrodeless Electrical Stimulator	Cadwell Laboratories, Inc.	GWF	Class II	1987-01-13
K863103	Peg 6,000	J. D. Assoc.	CHH	Class I	1987-01-13
K863054	Ast S.c.e. (Got)	J. D. Assoc.	CIT	Class II	1987-01-13
K862565	Chemtrol(tm)	G.B.F. Industries, Inc.	JJY	Class I	1987-01-13
K860132	Air Care Air Sanitizer	Cooper-Hewitt Electric Co.	FRA	Class II	1987-01-13
K870048	Additional Model to Canon Universal Stand	Canon Medical Components U.S.A., Inc.	KPX	Class II	1987-01-12
K865100	Tissue-Equivalent Breast Simulator	Computerized Imaging Reference Systems, Inc.	IXF	Class I	1987-01-12
K865033	Breast Prosthesis (Non & Inflatable) Skin Expander	Cox-Uphuff Intl.	LCJ	Unclassified	1987-01-12
K865024	Ankle Holder W/ankle Support Kit for Leg Holder	American Container Technology, Inc.	FWZ	Class I	1987-01-12
K865023	Cover, Shoe Operating Room	Ulti-Med Intl., Inc.	FXP	Class I	1987-01-12
K865022	Surgical Garments	Ulti-Med Intl., Inc.	FXO	Class I	1987-01-12
K865016	Blood Lancet	Falcon Medical Industries, Inc.	FMK	Class II	1987-01-12
K864920	Scanlan (Tm) Instrument Tray	Scanlan Intl., Inc.	FSM	Class I	1987-01-12
K864919	Scanlan (Tm) Vein/graft Holder	Scanlan Intl., Inc.	KPK	Class II	1987-01-12
K864897	Dale Venipuncture Tourniquet, Product No. 1335	Dale Medical Products, Inc.	GAX	Class I	1987-01-12
K864830	Teflon-Coated Hypodermic Needles/regional Block	Professional Instruments Co.	BXN	Class II	1987-01-12
K864829	Model Ns-3Cc Neuro-Stim Peripheral Nerve Stimulat	Professional Instruments Co.	BXN	Class II	1987-01-12
K864688	Arnold-King Pressure Dressing	Angiosystems, Inc.	NAD	Class I	1987-01-12
K864670	Board, Arm (with Cover)	Anago, Inc.	BTX	Class I	1987-01-12
K864547	Bird 6500 Air Compressor	Bird Products Corp.	BTI	Class II	1987-01-12
K864536	Ohmeda 5500 Airway Pressure Monitor	GE Healthcare	CAP	Class II	1987-01-12