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 2840 of 3529

510(k) clearances, page 2840 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864724	Modi. of Dental Ceramic for Fabrication of Crown	Dentsply Intl.	ELL	Class II	1987-02-17
K870473	Stat-Stand(tm) and Stat-Stand Ii(tm)	I.V. League Medical	FOX	Class I	1987-02-13
K870427	Extension/oscillator Table	Heidelberg Medical Products	JFB	Class II	1987-02-13
K870404	Colored Casting Tape (Red and Blue)	Buckman Co., Inc.	LGF	Class I	1987-02-13
K870349	Biodynamics Femoral Canal Brush #1201	Biodynamic Technologies, Inc.	HTR	Class I	1987-02-13
K870342	P3700 Col. Cna W/5% Sb	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-02-13
K870341	P1012 Be Agar	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-02-13
K870340	Z2017, Bea/cna 5%Sb Biplate	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-02-13
K870339	P4802 Bea	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-02-13
K870333	Biodynamics Small Joint Brush #1203	Biodynamic Technologies, Inc.	HTR	Class I	1987-02-13
K870329	Acetabular Brush #1202 & Femoral Con. Brush #1202	Biodynamic Technologies, Inc.	HTR	Class I	1987-02-13
K870264	Cat Epithelium Allergen Disc	Incstar Corp.	DHB	Class II	1987-02-13
K870236	Panoramic X-Ray Model Pc-1000	Panoramic Corp.	EHD	Class II	1987-02-13
K870062	Bicarbonate Procedure	Data Medical Associates, Inc.	KHS	Class II	1987-02-13
K870042	Assera-Plate Protein S Kit	American Bioproducts Co.			1987-02-13
K865034	Aztreonam 30 Mcg. Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1987-02-13
K864909	Du Pont Liquid Multi-Analyte Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIX	Class II	1987-02-13
K864875	Electra Automatic Sampler	Medical Laboratory Automation Systems, Inc.	JQW	Class I	1987-02-13
K864861	Instrumentations Unlimited Syringe System	Instrumentations Unltd.	EGM	Class II	1987-02-13
K864813	Wako (Tm) Autokit Got Test	FUJIFILM Healthcare Americas Corporation	CIT	Class II	1987-02-13
K864705	Modification (Material Change) of Peel-Away Sheath	Quinton, Inc.	DYB	Class II	1987-02-13
K864621	Vac - Rite Right Angle Aspirator Tube & Holder	Seldoren, Ltd.	EHZ	Class I	1987-02-13
K864519	Philips Computed Radiography System (PCR)	Parexel Intl. Corp.	LLZ	Class II	1987-02-13
K864512	Immuno-Plate IV Radial Immuno Test Kit/human Hapto	Cooper Biomedical, Inc.	DAD	Class II	1987-02-13
K864202	Utiscreen(r) Bacterial Atp Test	Los Alamos Diagnostics	JXA	Class I	1987-02-13
K863868	Immuno-Plate IV Radial Immuno Test Kit/alpha-1 Ant	Cooper Biomedical, Inc.	DFF	Class II	1987-02-13
K863236	Acuson S519b Transducer	Acuson Computed Sonography			1987-02-13
K860581	Qad-1 Angiodynograph Ultrasound System	Quantum Medical Systems, Inc.	IYO	Class II	1987-02-13
K870285	Thermometer Sheathes, Sterile (Glass)	Medical Group	FLK	Class II	1987-02-12
K870203	Keeler Lva System Multi-Cap Series Lva51-1/2/3/4/5	Keeler Instruments, Inc.	HKK	Class I	1987-02-12
K870153	Allergen Specific Igg4 Control Sera	3M Company	DHB	Class II	1987-02-12
K870112	Storz Ent/ophthalmic Maxi Chair	Storz Instrument Co.	HME	Class I	1987-02-12
K870072	Summit Optics Contact Lens Remover	Dayton Mfg. Co.	KYE	Class I	1987-02-12
K870068	Aspiration Reversal Control (Arc) Module	Optical Micro Systems, Inc.	HQE	Class II	1987-02-12
K870039	Imagenet Digital Ophthalmic Imaging System	Par Microsystems Corp.	DSF	Class I	1987-02-12
K865082	Prophy Care Solution	Imd, Inc.	EJR	Class I	1987-02-12
K864992	Raichem(tm) Creatinine Reagent (Enzymatic)	Reagents Applications, Inc.	JFY	Class II	1987-02-12
K864959	Obf Model 112 Vacuum Cup System	Ocular Blood Flow Laboratories, Inc.	HKX	Class II	1987-02-12
K864898	Foremost Dentin Adhesive	Foremost Dental Mfg., Inc.	EMA	Class II	1987-02-12
K864870	Thumbshelper Power Ring	Levolon Company, Inc.	LQX	Class I	1987-02-12
K864819	Raichem (Tm)serum Iron and Tibc Reagents	Reagents Applications, Inc.	JIY	Class I	1987-02-12
K864802	Dart Digoxin Assay	Coulter Electronics, Inc.	LCS	Class II	1987-02-12
K864775	Chisel (Osteotome, Gouge, Etc.)	New England Surgical Instrument Corp.	EMM	Class I	1987-02-12
K864572	Fixtector	Prodent Intl., Inc.	EFH	Class I	1987-02-12
K864104	Additonal Allergens for Ige Fast (Tm) Test	3M Company	DHB	Class II	1987-02-12
K863218	Cytostatic Filtration Set	Meadox Surgimed, Inc.	LFK	Class II	1987-02-12
K861821	Keymed Fiberscope Auto Disinfector	Keymed, Inc.	NVE	Class II	1987-02-12
K870429	Eusek-Bush in-Bath Filming Device (#Mc-00186)	The Mason Clinic	JAA	Class II	1987-02-11
K870247	Emit Quinidine Calibrator Item No. 67631/93	Em Diagnostic Systems, Inc.	DLJ	Class II	1987-02-11
K870143	Ammonia (Amon) Testpack, Item No. 67689/95	Em Diagnostic Systems, Inc.	JIF	Class I	1987-02-11