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 2766 of 3530

510(k) clearances, page 2766 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872572	Pharmanet (Tm)	Pharmacia, Inc.	EFQ	Unclassified	1988-01-14
K872453	Debrisan Absorbent Pad	Pharmacia, Inc.	KOZ	Class I	1988-01-14
K871712	Machida America Model Ac-5000 Automatic Disinfect.	Machida America, Inc.	NVE	Class II	1988-01-14
K872909	Siemens Sonodynator 834, Ultrasound/stimulation	Elmed, Inc.	IMG	Class II	1988-01-13
K875151	Acusyst-P/3x	Endotronics, Inc.	KJH	Class I	1988-01-12
K875136	Columbia Blood Agar P3308/ Columbia Cna P3750	Lakewood Biochemical Co., Inc.	JSG	Class I	1988-01-12
K875122	Disposable Sterile Syringe Filters	Corning Medical & Scientific	KET	Class I	1988-01-12
K875061	Monoject Samplette Amber Capillary Serum Separator	Sherwood Medical Co.	GIO	Class I	1988-01-12
K875035	Swede Petite (Wheelchair)	Etac Us, Inc.	IOR	Class I	1988-01-12
K875034	Swede Champ (Wheelchair)	Etac Us, Inc.	IOR	Class I	1988-01-12
K874771	Angiomed Introducing Sets	Angiomed U.S., Inc.	DWB	Class II	1988-01-12
K874336	Pattern Discrimination Perimeter	LKC Technologies, Inc.	HPT	Class I	1988-01-12
K874162	Optec Stain Characterization and Modification Kit	Pentron Corp.	EBF	Class II	1988-01-12
K873168	Spectramed Disposable Transducer (Dt-Xxo) & Access	Spectramed, LLC	DRS	Class II	1988-01-12
K875070	Albumin, Bromcresol Green Dye-Binding	Tech-Co, Inc.	CIX	Class II	1988-01-11
K875069	Bilirubin (Total)	Tech-Co, Inc.	CIG	Class II	1988-01-11
K874876	Gram - & Gram + Mic/combo & Breakpoint/combo Panel	Baxter Healthcare Corporation	JWY	Class II	1988-01-11
K874840	Bennett Portable Radiographic System No. Spr-100A	Bennett X-Ray Corp.	IZL	Class II	1988-01-11
K874626	Revised Labeling for Syva Phencyclidine Assays	Syva Co.	LCL	Unclassified	1988-01-11
K874624	Fiagen(tm) Hlh Catalogue Number: 102-301	Cyberfluor, Inc.	CEP	Class I	1988-01-11
K874621	Fiagen(tm) Prolactin Catalogue Number: 102-201	Cyberfluor, Inc.	CFT	Class I	1988-01-11
K874415	Pressure Limit Control	Draeger, Inc.	CBK	Class II	1988-01-11
K874382	Raichem(tm) Alcohol Reagent	Reagents Applications, Inc.	DML	Class II	1988-01-11
K874334	Solos Single Use Titanium Tip	Solos Ophthalmology	HQC	Class II	1988-01-11
K874251	Worth 4 Dot Test Distance C/w Muscle Light	Richmond Products, Inc.	HLP	Class I	1988-01-11
K874250	Three Char. Test-Child & Worth 4 Dot Test Nearpt.	Richmond Products, Inc.	HLP	Class I	1988-01-11
K874169	Ivt Northeast Allergy Screen	In Vitro Technologies, Inc.	DHB	Class II	1988-01-11
K874168	Ivt Southeast Allergy Screen	In Vitro Technologies, Inc.	DHB	Class II	1988-01-11
K874147	Qbc Blood Bank System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1988-01-11
K873405	Supervisor Sun Goggles(tm)	Eye Communications, Inc.	HQY	Class I	1988-01-11
K872942	Igm Cmv Clin-Elisa(tm) Test System Number: 5530	Clinical Sciences, Inc.	LKQ	Class II	1988-01-11
K872895	Haemonetics Cell Saver Mini Saver Auto. Blood Sys.	Haemonetics Corporation	CAL	Class I	1988-01-11
K872288	Sonolayer-V, Sal-38B	Toshiba Medical Systems	IYO	Class II	1988-01-11
K875092	Degania Silicone Tourniquet	Degania Silicone, Inc.	GAX	Class I	1988-01-07
K875050	Orthomet Bone Screws	Orthomet, Inc.	HWC	Class II	1988-01-07
K875009	In-the-Ear Hearing Aid	House of Hearing Aids, Ltd.	ESD	Class I	1988-01-07
K874919	Orthomet Wire for Suture, Cerclage	Orthomet, Inc.	JDQ	Class II	1988-01-07
K874913	Orthomet Pin System	Orthomet, Inc.	HTY	Class II	1988-01-07
K874891	Flexie the Copper Shank Needle	Skin Deep, Inc.	KCW	Class I	1988-01-07
K874820	Multichem Hdl Precipitating Reagent #S0914	Simmler Inc	LBR	Class I	1988-01-07
K874809	Reference High Level Assayed Chem. Control Serum	Biotrol, USA, Inc.	JJY	Class I	1988-01-07
K874604	Histobrush	Spectrum Co.	HHT	Class II	1988-01-07
K874575	Proximal Femoral Replacement Prosthesis	Dow Corning Wright	JDG	Class II	1988-01-07
K874531	Polyflex(r) Epicardial 439-04 Implant Pacing Lead	Intermedics, Inc.	DTB	Class III	1988-01-07
K874509	Playtex Non & Deodorant Tampons + Private Label	Playtex, Inc.	HIL	Class II	1988-01-07
K874385	Audiotone Model Msp, in-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1988-01-07
K874296	Infection Control Goggle (Tse Fong)/ster/non-Ster	Ulti-Med Intl., Inc.	FXX	Class II	1988-01-07
K873995	Bard Desai Catheter Electrode	C.R. Bard Inc	DRF	Class II	1988-01-07
K873874	Cardiofax-V ECG-8110A	Nihon Kohden America Inc	DSI	Class II	1988-01-07
K873158	Modified Multicor and Omni-Stanicor Pacemakers	Tpl-Cordis, Inc.	DXY	Class III	1988-01-07