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 2026-10-19, 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 3048 of 3529

510(k) clearances, page 3048 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842261	Ob Ultrasound Linear Scanner 630	GE Medical Systems Information Technologies, Inc.	HEM	Class II	1984-09-19
K842231	Ackrad Hysterosalpingography Set	Ackrad Laboratories	KNA	Class II	1984-09-19
K832466	Tracheal Tube 16 Gauge-1.65Mm-	Erie Medical	BTO	Class II	1984-09-19
K843372	Omnisound Therapy Unit	Physio Technology, Inc.	IMI	Class II	1984-09-18
K843351	Omnistim II Combin. Therapy Sys	Physio Technology, Inc.	IMG	Class II	1984-09-18
K840481	Infuse-a-Port Heparin Lock Maint Kit	Infusaid Corp.	LJT	Class II	1984-09-18
K834166	Bard CO2 Surgical Laser Sys Sls-50/100	C.R. Bard Inc	GEX	Class II	1984-09-18
K843356	Fiax 100 Fluorometer	Intl. Diagnostic Technology	JZT	Class I	1984-09-17
K843183	Stratus Cortisol Fluorometric Enzyme	American Dade	CGR	Class II	1984-09-17
K843181	Autofluor IV System	Tech America Diagnostics	DBM	Class II	1984-09-17
K843034	Disposable Linear Cutter	Ethicon, Inc	GDW	Class II	1984-09-17
K843006	Bard-Parker Flat/round Silicone Drain	BD Becton Dickinson Vacutainer Systems Preanalytic			1984-09-17
K842811	Ultrasystem Linscan Probe	Kelley Development Corp.	IYO	Class II	1984-09-17
K842475	Richards Intra-Articular Shaver Motor	Richards Medical Co., Inc.	GEY	Class I	1984-09-17
K842374	Novametrix 850 Transcutaneous Oxygen	Novametrix Medical Systems, Inc.	KLK	Class II	1984-09-17
K843429	Gram Stain Set W/stabilized Iodine	Accra Laboratories, Inc.	JTS	Class I	1984-09-14
K843418	Emit 700 Barbiturate Assay	Syva Co.	DIS	Class II	1984-09-14
K843397	Corning High Resolution Protein Electro	Corning Medical & Scientific	CEF	Class I	1984-09-14
K843378	Ethyl Alcohol Assay Kit	Diagnostic Chemicals, Ltd. (USA)	DMT	Class II	1984-09-14
K843332	Alkaline Phosphatase Reagent Set	Sterling Biochemical, Inc.	CJE	Class II	1984-09-14
K843330	Systemate Phosphorus 67217	Em Diagnostic Systems, Inc.	CEO	Class I	1984-09-14
K843327	Systemate Cholesterol 67222	Em Diagnostic Systems, Inc.	CHH	Class I	1984-09-14
K843326	Systemate Bun Hem No. 67221	Em Diagnostic Systems, Inc.	CDQ	Class II	1984-09-14
K843272	T.i.m.e. Dispenser	Dynatech Laboratories, Inc.	JTC	Class I	1984-09-14
K843255	Technicon Ra-1000 Sys Iron for Serum	Technicon Instruments Corp.	JIY	Class I	1984-09-14
K843244	Light Beam Collimator	Dealers X-Ray Co., Inc.	IZW	Class II	1984-09-14
K843238	Answer One-Day	Armkel, LLC	LCX	Class II	1984-09-14
K843210	Amikacin Calibrator Aca	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1984-09-14
K843194	V Agar Selective Deeps	Remel Co.	JSI	Class I	1984-09-14
K843193	Strep Selective II	Remel Co.	JSI	Class I	1984-09-14
K843177	Inorganic Phosphorus Test	Sclavo, Inc.	CEO	Class I	1984-09-14
K843174	Dri-Stat Enzymatic Bilirubin Test Kit	Beckman Instruments, Inc.	JFM	Class II	1984-09-14
K843162	Emit 700 Opiate Assay	Syva Co.	DJG	Class II	1984-09-14
K842957	Coritsol Premix Ria Kit	Biotecx Laboratories, Inc.	CGR	Class II	1984-09-14
K842947	Microbiological Tray Reader-Manual	American Micro Scan	JJQ	Class I	1984-09-14
K842938	Acetic Acid 1% V/v	E K Ind., Inc.	GGK	Class I	1984-09-14
K842786	Dyna-Lyte 2000	Abbott Diagnostics	CEM	Class II	1984-09-14
K842770	Macbeth Color Eiad 100/100Pc	Macbeth	JJQ	Class I	1984-09-14
K842499	Nms 1043 Enzyme Immunoassay Kit	Nms Pharmaceuticals, Inc.	JHI	Class II	1984-09-14
K842478	Prolactin Irma	Euro-Diagnostics BV	CFT	Class I	1984-09-14
K841319	Rotalex Latex Agglutination Test	Orion Diagnostica, Inc.	LIQ	Class I	1984-09-14
K843439	Centurian Hydraulic Stretcher	American Sterilizer Co.	FPO	Class II	1984-09-13
K843325	Systemate Uric Acid, Hem 67220	Em Diagnostic Systems, Inc.	KNK	Class I	1984-09-13
K843296	Elvi 675 Digitron	Logos Scientific, Inc.	JJQ	Class I	1984-09-13
K843270	Systemate Alkaline Phosphatase-67203	Em Diagnostic Systems, Inc.	CJE	Class II	1984-09-13
K843269	Systemate Ldh, 67210	Em Diagnostic Systems, Inc.	CFJ	Class II	1984-09-13
K843268	Systemate 2Gt - 67207	Em Diagnostic Systems, Inc.	JQB	Class I	1984-09-13
K843266	Id Zone Normal Ld Isoenzyme Control	Beckman Instruments, Inc.	JJT	Class I	1984-09-13
K843265	Id Zine Ld Isoenzyme Control Abnorm	Beckman Instruments, Inc.	JJT	Class I	1984-09-13
K843112	Roche Standards for Uric Acid	Roche Diagnostic Systems, Inc.	JIT	Class II	1984-09-13