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 2818 of 3530
510(k) clearances, page 2818 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K871804Mcconnel Orthopedic Arthroscopy Support AssemblyMcconnell OrthopedicFWZClass I
K871803Mcconnell Orthopedic Universal Positioner (Mup)Mcconnell OrthopedicFWZClass I
K871703Mcconnell Orthopedic Sterile Articulated ArmMcconnell OrthopedicFWZClass I
K871669Babyset(tm) Modified Jackson-Rees Circuit W/valveLife Design Systems, Inc.CAIClass I
K871525Dahlberg Model Ul in-the-Ear Hearing AidDahlberg Electronics, Inc.ESDClass I
K871519Telstar Model 0/3 Hearing AidTelstar Electronics, Inc.ESDClass I
K871045Dmi Ambulatory Holter MonitorDiagnostic Medical InstrumentsDSHClass II
K871038Lutemoll (Bioplast)B. L. Dental Co.EBIClass II
K864869Hr-5000 Electrosurgical DeviceIme Co., Ltd.KCWClass I
K871730Modified Use of Pull-Apart Introducer SetQuinton, Inc.FKOClass II
K871706Optha PrepTreace Medical, Inc.HMTClass II
K871676Enzymatic Cholesterol Reagent SetMichClone Associates, Inc.CHHClass I
K871646Tanne Corneal Cutting BlockOcular Instruments, Inc.HNJClass I
K871639Dental Diamond BursE&D Dental Manufacturing Co.DZPClass I
K871611Allergan Humphrey Auto-Refractor, Models 525 & 540Allergan HumphreyHKOClass I
K871591Ormco Gel-EtchScientific Pharmaceuticals, Inc.DYHClass II
K871564AnesthassistAnestech, Inc.BRYClass I
K871531Reagents 1263,1273,1284,1425,014301,053583American Research Products Co.CIGClass II
K871401Kirschner Modular Hip SystemKirschner Medical Corp.JDIClass II
K871335Topcon Computerized Tonometer CT-10Topcon Instrument Corporation of AmericaHKXClass II
K871032Model 20-C with an Sa-20A/u Opt. Attach. Hemorrho.Directed Energy, Inc.LNKClass II
K871029Model 20-C with an Sa-20B/u Opt. Attach. Hemorrho.Directed Energy, Inc.LNKClass II
K870782Cyclo-BrushMEDLINE INDUSTRIES, LP - NorthfieldHHTClass II
K871725Dripride Disposable UnderpadsWeyerhaeuser Co.KMEClass I
K871709Anaerobic Transport Pouch (Catalyst-Free)Difco Laboratories, Inc.KZJClass I
K871690Emed-F-SystemNovel GmbHIKEClass I
K871674Ticarcillin/clvulinic Acid 85 Mcg Susceptibility DbioMerieux, Inc.JTNClass II
K871606Spottest Flagella StainDifco Laboratories, Inc.JTSClass I
K871559Cell LifterCorning Costar Corp.LIBClass I
K871343Qm2/qm300 Buffer and Diluent PackKallestad Diag, A Div. of Erbamont, Inc.CFNClass II
K871339Kallestad Qm300 Protein Analysis SystemKallestad Diag, A Div. of Erbamont, Inc.JQPClass I
K871193I-125 Anti-Thyroglobulin Antibody Irma Test KitCronusJZOClass II
K871151The Spira Elektro 2Warren E. Collins, Inc.CCQClass I
K871108Gambro Polyflux 130 and 160 HemodialyzerGambro, Inc.KDIClass II
K871066Curity Continuous Epidural Anesthesia TrayThe Kendal Co.CAZClass II
K87103110-C/sa-10B/u Opt 20-C/20a/u Beam Sa-10B/u HemorrhDirected Energy, Inc.LNKClass II
K871030Model 10-C with an Sa-10A/u Opt. Attach. Hemorrho.Directed Energy, Inc.LNKClass II
K871027Precinorm(r) ProteinBoehringer Mannheim Corp.DAFClass II
K871024Precimat(r) C3Boehringer Mannheim Corp.CZWClass II
K870428Aerosol One, Nebulizer PumpAshai Co., Ltd.BTIClass II
K861291GastrotopoHouston Biomedical, Inc.FGEClass II
K871660Western Ragweed Allergen DiscIncstar Corp.DHBClass II
K871542Hprolactin KitImmuchem Corp.CFTClass I
K871535Smiljanic Bone Repositioning ForcepsLink America, Inc.HTDClass I
K871530Total Bilirubin Reagent 1372,1425,1284,1273,053583American Research Products Co.CIGClass II
K871461Vision (Tm) Hdl CholesterolAbbott MedicalLBSClass I
K871366Siemens Main Flow Bacteria FilterSiemens Elema ABCAHClass II
K871351H-H Harris Neonatal Nasal Cannula Set for CPAPHolter-Hausner Intl.BZDClass II
K871116X-Cel X-Ray Models Ort90w, Ort90m and Ort90rX-Cel X-Ray CorpIYHClass II
K871023Precimat(r) C4Boehringer Mannheim Corp.DBIClass II