510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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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 , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,132 of the 176,529 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
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 1679 of 3531
510(k) clearances, page 1679 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K000494Synchron Systems Acetaminophen (Actm) ReagentSiemens Healthcare Diagnostics Inc.LDPClass II
K000486Abc Cervical Plating SystemAesculap IncKWQClass II
K000467Urine Cocaine Metabolite (Coc) Screen Flex Reagent Cartridge, Catalog No. Df 92ASiemens Healthcare Diagnostics Inc.DIOClass II
K000464Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. Df 90ASiemens Healthcare Diagnostics Inc.DJGClass II
K000460Urine Amphetamine/methamphetamine (Amph) Screen Flex Reagent, Catalog No. Df 90ASiemens Healthcare Diagnostics Inc.DKZClass II
K000437Interventional Body CoilGE Healthcare CoilsMOSClass II
K000411Chili Video, Chili VideoproSteinbeis-Transferzentrum Medizinische InformatikLMAClass II
K000373939Udx Urine Pathology SystemIntl. Remote Imaging SystemsLKMClass II
K000366Fixation Stylets, Models 335-287 and 335-288Accufix Research InstituteDRBClass II
K000346Ez ConnectKerr Dental Materials CenterEBGClass II
K000290Lazersmile, LazerwhiteBiolase MG LLCEFWClass I
K000241Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp.GEIClass II
K000238Hsv-1 & Hsv-2 Differentiation Immunoblot Igg, Model Ib0900gMrl DiagnosticsLGCClass II
K000223Nitrile Patient Examination Gloves, Powder-FreePhoenix Medical Technology, Inc.LZAClass I
K000126Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/pediatric Disposable Sensor, Masimo Lno-Pdt-PediaMasimo CorporationDQAClass II
K994240Ex 45-Bp, Model 330 132; Ex 53-Bp, Model 130 018; Ex 60-Bp, Model 330 133BIOTRONIK AGDTBClass III
K994221Bayer Psa AssayBayer Corp.LTJClass II
K994164Ontrak Teststik 2 for Cocaine/thc, Cat. 1118579Roche Diagnostics GmbHLDJClass II
K994027Activator PasteHarry J. Bosworth Co.ELWClass II
K993695Liga-Loop Suture ApplicatorHysterx, Inc.GALClass II
K993608Datex-Ohmeda Ne12stpr Module (Model Family M-Ne12stpr)GE HealthcareMHXClass II
K992942Lemaitre Occlusion CatheterVascutech, Inc.MJNClass II
K992664Tfx Medical Stylet CatheterTfx Medical GroupDRBClass II
K000829Gatifloxacin, 5 Ug, Bbl Sensi-DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K000824Percutaneous Introducer, Model 10383-XxxGreatbatch MedicalDYBClass II
K000810Qualitrol Lipid Control, Levels 1 and 2Consolidated Technologies of WisconsinJJYClass I
K000661Randox PrealbuminRandox Laboratories, LimitedJZJClass I
K000646Disposable Injector or Disposable Sclerotherapy NeedleEnteric Medical TechnologiesFBKClass II
K000570Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, Xxl Balloon Dilatation Cathater, Symmetry Balloon DilaBoston Scientific CorporationLITClass II
K000526Hardydisk, Cephalothin 30McgHardy DiagnosticsJTNClass II
K000206Pals Neonatal Pediatric ECG Electrode, Models Pn100, Pn200Axelgaard Mfg. Co., Ltd.DRXClass II
K000199Cortek Mini LaparoscopeCortek Endoscopy, Inc.HETClass II
K000168Cs/3 Critical Care Monitor with S-Icu99(a)GE HealthcareMHXClass II
K000147Ctc Dvt-1 Calf Garment, Model Dvt-1Compression Therapy Concepts, Inc.JOWClass II
K000117Avid-Nit Cervical Regional Anesthesia NeedleAvid Medical, Inc. a Medical Action Ind. Company 305HEEClass II
K000112Acucam Concept IV, Models A1222b, A1223b, A1221b, A1121b, A1222c, A10402, A10403, A10401Dentsply Intl.EIAClass I
K994099Vinyl Patient Examination Gloves-Pre-PowderedEvergreen Medical Produts (Jingxing) Co., Ltd.LYZClass I
K993116A&d Medical Ut-101 Lifesource Digital Ear TherometerA and D Engineering, Inc.FLLClass II
K992553Iq ChambersDormer Laboratories, Inc.KXFClass I
K991677Regent Skindende Exam Glove, Regent Biogel D, Regentbiogel Diagnostic (Powderfree)London International Group, Inc.LYYClass I
K001008Tempteller Infrared Ear Thermometer, Models Tt-901, Tt-911 and Tt-921Oriental System Technology, Inc.FLLClass II
K0007931 Otw Viatrac 18 Peripheral Dilatation CatheterBoston Scientific CorporationFGEClass II
K000740Asahi Sterile Acupuncture Needle Type SAsahi Iryoki Co., Ltd.MQXClass II
K000688Uniglove Nitrile Powdered Examination GlovesN.S. Uni-Gloves Sdn. Bhd.LZAClass I
K000670Nitrile Exam Glove, Powder Free, BlueShasta Asia Partners Gloves Manufacturing CO, Ltd.LZAClass I
K000584Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Shasta Asia Partners Gloves Manufacturing CO, Ltd.LYYClass I
K000555Tekmedic Powdered Single-Use Latex Patient Examination Gloves with Protein & Powder Label Claim Contains 70Mgm or Less OTekmedic (M) Sdn BhdLYYClass I
K000426Vip- Variable Intensity PolymerizerBisco IncEBZClass II
K000391Vital Shield Gold Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Sgmp Co., Ltd.LYYClass I
K000390Vital Shield Gold Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)Sgmp Co., Ltd.LYYClass I