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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3368 of 3526

510(k) clearances, page 3368 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800195	Cotton Under Cast Padding	Winn Hirsch & Assoc.	ITG	Class I	1980-02-11
K800194	Ovalith P-Bp Bipolar Cardiac Pacemaker	Coratomic, Inc.	DXY	Class III	1980-02-11
K800184	Oxford External Fixation System	Downs Surgical, Ltd.	JEC	Class II	1980-02-11
K800179	Infrasonde Auto/inflator Elec. Vibrator	Sphygmetrics, Inc.	DXW	Class II	1980-02-11
K800177	I.m. Blades	Instrument Makar, Inc.	GDX	Class I	1980-02-11
K800162	Once Tm	G.D. Searle and Co.	HDW	Class II	1980-02-11
K800139	Searle Pho/sonic Alpha 2000	G.D. Searle and Co.	IYO	Class II	1980-02-11
K800131	Centrifichem Alp/alkaline Phosphatase	Union Carbide Corp.	CJE	Class II	1980-02-11
K800117	Tru-Pulse Pads	Ipco Corp.	GXY	Class II	1980-02-11
K800113	Sears Behind-the-Ear Hearing Aid	Int'L Hearing Aids, Inc.	ESD	Class I	1980-02-11
K800105	Telesonic (Hearing Aid)	Telesonic, Inc.	ESD	Class I	1980-02-11
K800098	Minifeton 200	Kt Medical, Inc.	KNG	Class II	1980-02-11
K800097	Minivason 9	Kt Medical, Inc.	JAF	Class II	1980-02-11
K800096	Ambivason Dr-200	Kt Medical, Inc.	JAF	Class II	1980-02-11
K800095	Mgd-3	Kt Medical, Inc.	KNG	Class II	1980-02-11
K800094	Combison 200 & Combison 202	Kt Medical, Inc.	IYO	Class II	1980-02-11
K800093	Transducer	Kt Medical, Inc.			1980-02-11
K800091	Combison 100-Model 100 & 110	Kt Medical, Inc.	IYO	Class II	1980-02-11
K800062	Pipet Calibration Kit	Streck Laboratories, Inc.	JIS	Class II	1980-02-11
K800057	Micro Elisa Mini Reader	Dynatech Laboratories, Inc.	JJQ	Class I	1980-02-11
K800022	Model 807 Suction Cautery Finger Tip	Malibu Laboratories	GEI	Class II	1980-02-11
K792669	Corometrics-Push Button Spiral Electrode	GE Medical Systems Information Technologies, Inc.	HGP	Class II	1980-02-11
K792646	Amp Direct Vascular Monitoring System	American Medical Products LLC	KRH	Class II	1980-02-11
K792270	Dexide Disposable Prep Stick W/iodophor	Dexide, Inc.			1980-02-08
K792520	Anesthesia & Hospital Syringe Holder	Medical Innovations, Inc.	FMF	Class II	1980-02-07
K800210	Tongue Holder/saliva Ejector	Unitek Corp.	DYN	Class I	1980-02-06
K800153	Extemp/extemp-V	Pharma-Filter, Inc.	GAA	Class I	1980-02-06
K800110	X-Flo	Contemporary Surgical Systems, Inc.	HQE	Class II	1980-02-06
K800104	Royco Model 951 Cell Mixer	Royco Instruments	KSQ	Class I	1980-02-06
K792651	Capd Transfer Set Jc9044	Travenol Laboratories, S.A.	KDJ	Class II	1980-02-06
K792648	Unilab Culturing Set	Sybron Corp.	FRC	Class II	1980-02-06
K792611	Gambro Lundia Plate Dialyzer	Gambro, Inc.	FJG	Class II	1980-02-06
K792597	Rectal Leakage Inhibitor	Augustin Jones, M.D.	KNT	Class II	1980-02-06
K791512	Continuous Ambulatory Dialysis (Capd)	Norton Performance Plastics Corp.	KDJ	Class II	1980-02-06
K800193	Medtronic Pisces Generation II Lead Kit	Medtronic, Inc.	GZB	Class II	1980-02-05
K800172	Siroport	Siemens Corp.	KLC	Class I	1980-02-05
K800167	Immunoglobulin M Reagent System	Calbiochem-Behring Corp.	DFT	Class II	1980-02-05
K800163	Vimedic System Tm	Medical Systems Group of Viskay, Inc.	EFA	Class I	1980-02-05
K800154	Tote-Brush	Anja Marketing, Inc.	EFW	Class I	1980-02-05
K800151	Emit Tobramycin Control	Syva Co.	DPW	Class II	1980-02-05
K800150	Emit Tobramycin Assay	Syva Co.	LCD	Class II	1980-02-05
K800146	Platelet Aggregation Reagents	Pacific Hemostasis	JOZ	Class II	1980-02-05
K800124	Ultrasoft Gown	Mars Mfg Co.	FYA	Class II	1980-02-05
K800121	Technicon C/90 System	Technicon Instruments Corp.	GKZ	Class II	1980-02-05
K800119	Immunoglobulin G Reagent System	Calbiochem-Behring Corp.	DEW	Class II	1980-02-05
K800118	Chick Surgical Table	Warner-Lambert Co.	FWY	Class I	1980-02-05
K800082	Storz Super Sorb Micro Eye Sponge	Storz Instrument Co.	EFQ	Unclassified	1980-02-05
K800078	Briox Model-Aeromist	Briox Technologies, Inc.			1980-02-05
K800073	Transcutaneous Oxygen Monitor	Biochem International, Inc.			1980-02-05
K800071	Bun Reagent Kit	Fisher Scientific Company L.L.C.	CDS	Class II	1980-02-05