510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 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
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
20262,669
176,466 records, page 2642 of 3530
510(k) clearances, page 2642 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891459Sterile Burnnet Pre-Cut (Various Sizes)Western Medical, Ltd.NADClass I
K891407Leucoprep Cell Separation TubeBD Becton Dickinson Vacutainer Systems PreanalyticJCFClass I
K891161Vitrectomy Pack #J120O.R. Specialties, Inc.HQCClass II
K891092Temptek 5010 Thermal Cooling BlanketTemptek, Inc.ILOClass II
K891020Espe Tulux-CemEspe GmbH (US)EBFClass II
K890825Jumper Pack #203O.R. Specialties, Inc.HQCClass II
K890088Acudata Indicatens Model 5XAcudata SoftwareGZJClass II
K883794Resubmitted Clw Acetabular Cup W/sulmeshProtek, Inc.LWJClass II
K882084Genesis Tm Fetal SystemPediatric Diagnostic ServiceHGMClass II
K892862Flex-Cup PercussorLife Design Systems, Inc.BYIClass II
K892823Plaster Cutting ScissorsThe South India Surgical Co. Pvt., Ltd.LRWClass I
K892761Patient Examination Gloves (Latex)E-Full Industrial, Ltd.LYYClass I
K892742Patient Examination Gloves (Latex)Shen Wei (USA), Inc.LYYClass I
K892686Patient Exam Gloves (Mfg. Polymint Industrial Co.)Intl. Visco GroupLYYClass I
K892683Patient Examination Gloves (Latex)Vollrath Group, Inc.LYYClass I
K892567Patient Examination Gloves (Latex)Anhui Light Industrial Products I/E Corp.LYYClass I
K892554Sterile Patient Examination GloveShun Thai Rubber Gloves Industry Co., Ltd.LYYClass I
K892553Maytex Patient Examination GlovesAmerican Seal Co.LYYClass I
K892462Patient Examination GlovesHollymount Trading & Mfg.LYYClass I
K892353Perry* Non-Sterile X-Am* GlovesSmith & Nephew Medical LtdLYYClass I
K892304Patient Examination Gloves (Latex)Saraf Chemicals Pvt., Ltd.LYYClass I
K892111Patient Examination Gloves (Latex)Maika Holdings Sdn. Bhd.LYYClass I
K892026Prolax Patient Examination Gloves (Latex)Ergo Intl., Ent., Inc.LYYClass I
K892025Patient Exam Gloves (Mfg. Beijing Latex Factory)Brilliant Ray Intl., Inc.LYYClass I
K892024Patient Exam Gloves (Mfg. Chagan Tang Capitol)Brilliant Ray Intl., Inc.LYYClass I
K892023Patient Exam Gloves (Mfg. Xian Welfare Latex )Brilliant Ray Intl., Inc.LYYClass I
K892022Patient Exam Gloves (Mfg. Yu Hua Latex Factory)Brilliant Ray Intl., Inc.LYYClass I
K891959Yupond Latex Examination GlovesYupond Ent. Co., Ltd.LYYClass I
K891949Patient Examination Gloves (Latex)Phoenix Medical Technology, Inc.LYYClass I
K891881Patient Examination Glove (Latex)Cymun Development Sdn BhdLYYClass I
K891865Nil (Patient Examination Gloves - Latex)Medicare Industries, Inc.LYYClass I
K891864Patient Examination Gloves (Latex)Pt Latexindo LestariLYYClass I
K891736Patient Examination Gloves (Latex)Quest Intl., Inc.LYYClass I
K891728Latex Exam Gloves (Mfg. Koon Seng Sdn Bhd)Baldur Systems Corp.LYYClass I
K891661Patient Examination Gloves (Latex)Dmp, Inc.LYYClass I
K891488Mobilaire V Oxygen ConcentratorInvacare GmbHCAWClass II
K891107Indicatens Indicator Electrode Model 2Acudata SoftwareGXYClass II
K891105Indicatens Model 4X4 Sp Electrode Stim. PatchesAcudata SoftwareGXYClass II
K890144Oxitron Oxygen SensorOxitron Medical ProductsCCLClass II
K885139Modified Adult Cricothyroidotomy KitPertrachBTOClass II
K893012Argelite 60+Argen Precious Metals, Inc.EJTClass II
K892894S-File, S-Finder, S-Engine FileSvenska Dental Instruments ABEKSClass I
K892662Argedent 87Argen Precious Metals, Inc.EJTClass II
K892658Sdi Prepax Countapette KitScientific Distributors, Inc.JCGClass I
K892648Microvasive Endotorque Guidewire, Cat #5177Boston Scientific CorporationOCYClass II
K892522Sr30/sr50/sr60 Auto Sediment Rate System, ModifiedGespac, Inc.GKBClass I
K892395Amresco Uric Acid Reagents #7628American Research Products Co.KNKClass I
K892263Merifluor(tm) -TrichomonasMeridian Diagnostics, Inc.JWZClass I
K891770Hcg Irma IIPacific Biotech, Inc.JHIClass II
K891467Lokshot Piston SyringeFlp Ent., Inc.FMFClass II