510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3299 of 3528
510(k) clearances, page 3299 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810715SecureSci-Pharm, Inc.DYHClass II
K810574Suction Collection Bottle, DisposableHarvard LaboratoriesKDQClass II
K810310K-Y Lubricating JellyJohnson & Johnson Professionals, Inc.KMJClass I
K810049Pedicat*Pollak (Intl.).ltdKMJClass I
K802918Anthron Catheter SetNational Catheter Co. Div. MallinckrodtFOZClass II
K810965Data-Zyme TriglycerideData Medical Associates, Inc.CDTClass I
K810964Bio Set Tm Phosphorous CalibratorBoehringer Mannheim Corp.JIXClass II
K810963Bio Set Tm Substrate CalibratorsBoehringer Mannheim Corp.JISClass II
K810957Marcove Intramedullary RodHexcel MedicalHSBClass II
K810956Marcove Humeral RodHexcel MedicalHSBClass II
K810952Corning Vitamin B12 Folate Defic. Contr.Corning Medical & ScientificJJYClass I
K810948Radioimmunoassay Thyroid Stim. Horm. KitEndocrine-Metabolic CenterJLWClass II
K810943Ames Tda Theophylline TestMiles Laboratories, Inc.LERClass II
K810942Ames Tda Gentamicin TestMiles Laboratories, Inc.LCQClass II
K810941Ames Tda Tobramycin TestMiles Laboratories, Inc.LCRClass II
K810936Chorio-ShureNuclear Medical Laboratories, Inc.JHIClass II
K810924Medrad High Pressure Conecting TubeMedrad, Inc.DWEClass II
K810909Micro CauteryKey Medical, Inc.HAMClass II
K810896Venti-Gard Jr.Con Med Equipment, Inc.KGXClass I
K810892Electro-Suction UnitJEDMED Instrument CompanyKDQClass II
K810877Orthosis BandagesOrtho-Cast, Inc.ITGClass I
K810854Kangaroo Nasogastric Feeding TubeChesebrough-Pond'S U.S.A. Co.KNTClass II
K810849Cordis Biopsy ForcepsCordis US Corp.DWZClass II
K810846Sween Universal Bed Rail PadsSween Corp.FNJClass I
K810824Erika Heparin Infusion AdaptorErika, Inc.FJKClass II
K810823Erika Extension SetsErika, Inc.FJKClass II
K810812Draining-Wound Mgmt. SystemJohnson & Johnson Professionals, Inc.EXBClass I
K810810Amicon Ultrafiltration Membranes CmiiAmicon, Inc.DHXClass II
K810788Surgical Tube HolderThe Urology GroupFZXClass I
K8107495 Mhz TransducerGeneral Electric Co.ITXClass II
K810737Endotracheal Tube HolderAircare SystemsCBHClass I
K810679Ms-303-Oxygen Regulator ShieldInstrumentation Industries, IncorporatedCANClass I
K810665Gilucochek Reflectance MeterLifescan, Inc.JJQClass I
K810640Polarised Light GroniometerCairco, Ltd.KQXClass I
K810621Disposable 22Mm. Flexible AdaptorIntec Medical, Inc.BZAClass I
K810508Sontek Angiographic CatheterSontek Corp.DQOClass II
K810470Shiley S-100A (Adult) Blood OxygenatorShiley, Inc.DTZClass II
K810311Steri-VersThe Hilrad Co.LDSClass II
K810285Barnes-Hind Rose Bengal Ophthalmic Str.Barnes-Hind, Inc.KYC
K810215Dac-Cel HcgBurroughs Wellcome Co.JHIClass II
K810038Digital Diagnostic Ultrasound DeviceRohe Scientific Corp.IYOClass II
K802818Pullen Pocket ScopeP.A. Research Corp.IBJClass I
K802447Got Isoenzyme Assay Eiken KitSyn-Kit, Inc.CITClass II
K811028Pace AidCardiac Resucitator Corp.
K810242Utensil & Procedure TraysAmerican Hospital SupplyFRLClass I
K810933Votel-Johnson Agar (Modified)Oxoid U.S.A., Inc.JSIClass I
K810932VitoxOxoid U.S.A., Inc.JSKClass I
K810931Ss Agar (Modified)Oxoid U.S.A., Inc.JSIClass I
K810929Perfringens Agar BaseOxoid U.S.A., Inc.JSIClass I
K810927Respiratory Intensive Care System (Rics)Allied Medical LLCCCKClass II