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 2622 of 3530
510(k) clearances, page 2622 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K892193Quickpad (Alcohol Swabs)Holtsch Co., Inc.LKBUnclassified
K892068Trt (Acuson) Needle Guide Kit, SterileAmedic USAFCGClass II
K884261Prowess 2000Small Systems Group, Inc.KPQClass II
K894435Vax-T Pelvic Traction BeltVat-Tech, Inc.ITHClass II
K894425Acs Human Plasma Coagulation Control Level IIIAnalytical Control SystemsGGCClass II
K894422Tuffcare Medical Products WheelchairTuffman IndustriesIORClass I
K894346D88vs Wheelchair Power SystemDamacoITIClass II
K894327Emit D.a.u. Low & Medium Calibrator aSyva Co.DKGClass I
K894301Micro-Aire Sternum Saw 4800Micro Surgical Instruments Corp.KFKClass I
K894249Universal Cemented CupMizuho Orthopedic Systems IncJDIClass II
K894234Sensocor Tm R-Test 24OxlSensocorDXGClass II
K894161Asc-950 ECG AmplifierAstro-Med, Inc.DRRClass II
K894159Opus Immunoassay SystemPb Diagnostic Systems, Inc.KHOClass I
K894110Qualicheck 2Radiometer America, IncJJSClass I
K894091Amerlex-Mab Ft4 KitAmersham Corp.CECClass II
K893961Abbott Imx(tm) D-DimerAbbott MedicalGHHClass II
K893950Ventipress 24 and 14 Pressure VentilatorVentipress OyIRPClass II
K893905Pathodx(tm) Chlamydia Direct Specimen (Pdcy1)Siemens Healthcare Diagnostics Inc.LIOClass I
K893900Primapore i.v.Smith & Nephew United, Inc.KGXClass I
K893871Goott Balfour BladeAdept-Med Intl., Inc.GADClass I
K893869Goott Multipurpose Flexible Retractor (Sterile)Adept-Med Intl., Inc.GADClass I
K893860Abuscreen Ontrak Pos.ref.control for PhencyclidineRoche Diagnostic Systems, Inc.LASClass I
K893859Abuscreen Ontrak Pos. Ref. Control for CocaineRoche Diagnostic Systems, Inc.LASClass I
K893858Abuscreen Ontrak Pos. Reference Control for ThcRoche Diagnostic Systems, Inc.LASClass I
K893857Abuscreen Ontrak Pos. Ref. Control for AmphetamineRoche Diagnostic Systems, Inc.LASClass I
K893856Abuscreen Ontrak Pos. Ref. Control for MorphineRoche Diagnostic Systems, Inc.LASClass I
K893855Abuscreen Ontrak Pos. Ref. Control for BarbituatesRoche Diagnostic Systems, Inc.LASClass I
K893854Cobas Fara II Centrifugal AnalyzerRoche Diagnostic Systems, Inc.JJGClass I
K893810Immuno-Wash Automated Tube WasherOcean Scientific, Inc.JQWClass I
K893776Abbott Asset Automated Clinical Chemistry AnalyzerAbbott MedicalJJEClass I
K893715Ethicon Disposable Surgical TrocarEthicon, IncHETClass II
K893683Sarns Pressure Adjustable Safety System3M CompanyDTLClass II
K893658Percutaneous IntroducerGreatbatch MedicalDYBClass II
K893639Gamma Locking NailHowmedica Corp.KTTClass II
K893577Status Hcg Fluorometric EnzymeBaxter Healthcare CorporationDHAClass II
K893548Seralyzer Hdl Cholesterol Procedure Use W/stripKulzer GmbHLBSClass I
K893547Clinimate-Tda Blood Chemistry AnalyzerKulzer GmbHJJEClass I
K893470Siemens Sao2 + Puls Oximetry CartridgeSiemens Medical ElectronicsDQAClass II
K893419Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)Coulter ImmunologyDEWClass II
K893404Integra(tm) Blood Glucose Monitoring SystemApprise, Inc.CGAClass II
K893403Models Hp 43110Mc, 43200Mc W/case & 43200M No CaseHewlett-Packard Co.LDDClass II
K893264Latex Examination GlovesP.T. Kreasi BhojwanisLYYClass I
K893134Apaceram Ossicular ProsthesisAsahi Optical Co. C/O Rosati Associates, P.C.ETBClass II
K892982Patient Latex Examination GlovesAtaro Industri (Malaysia) Sdn BhdLYYClass I
K892981Patient Examination GlovesLapoma Gloves Industries Sdn. Bhd.LYYClass I
K892971Latex Exam GlovesP.C. Commercial, Inc.LYYClass I
K892940Precious Lite Model 4224E & B Technologies, Inc.LBIClass II
K892800Mg II Porous Total Knee SystemZimmer GmbHJWHClass II
K892730Ifa Sensibac ChlroamphenicolInvestigacion Farmaceutica S.A. de C.V.JTNClass II
K892729Ifa Sensibac TobramycinInvestigacion Farmaceutica S.A. de C.V.JTNClass II