510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2883 of 3529
510(k) clearances, page 2883 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K862751USA AspiratorU. S. A. Medical Corp.BTAClass II
K862703Emds(tm) Elevated Lipid Calibrator #67626/95Em Diagnostic Systems, Inc.JIXClass II
K862607Imagen(tm) Chlamydia Specimen Collection KitBoots-Celltech Diagnostics, Inc.LIOClass I
K862587Chemtrol(tm)G.B.F. Industries, Inc.JJYClass I
K862586Chemvarion(tm)G.B.F. Industries, Inc.JJYClass I
K862572Hollister Wound Care BarrierHollister, Inc.FROUnclassified
K862542Capillary Columns for Gas ChromatographySupelco, Inc.DIIClass I
K862440Paramax Lipase ReagentAmerican DadeCETClass I
K862420Utak-Stabbs Toxicology ControlUtak Laboratories IncJJYClass I
K862278Gas-TrakUnited Diagnostics, Inc.JJYClass I
K862248Amikacin Kit (Fpia)Windsor Laboratories, Inc.LGJClass II
K862206Taurus (Tm) Automatic Liquid Scintillation CounterMicromedic SystemsJJJClass I
K862185Lyphochek Pediatric and Bilirubin ControlBio-RadJJYClass I
K861974Perceptive Systems Inc Psicom 217 Karyotyping SystPerceptive Systems, Inc.LNJClass II
K861368Medtronic Model 5328 Programmable StimulatorMedtronic, Inc.JOQClass II
K860922Mikros, Mikros Vs-1, Pulse GeneratorBiotronik Sales, Inc.DXYClass III
K860828Foretel, Color Ovulation TestNms Pharmaceuticals, Inc.CEPClass I
K860679Immunochemical Assay of C-Reactive ProteinOrion Corp.DCNClass II
K860511Ampu-PakAmmerman Medical Enterprises, Inc.LPZUnclassified
K855178Diatron Blood Glucose MeterDextron, Inc.CGAClass II
K854329Diagem 300 Bg Reagent StripsSeton Products, Inc.CGAClass II
K862828Bsx Bucky-StandGarrels X-Ray Products, Inc.IXYClass I
K862827Fcw Tube StandGarrels X-Ray Products, Inc.IYBClass I
K862826Itt Intergrated Table and TubestandGarrels X-Ray Products, Inc.IXQClass II
K862802Multi-Channel MicropipettesDynatech Laboratories, Inc.JTCClass I
K862795Mp-070-M Radioaerosol KitMedipart Jerry AlexanderIYTClass II
K862794Mp-070 Radioaerosol KitMedipart Jerry AlexanderIYTClass II
K862793Mp-066-M Radioaerosol KitMedipart Jerry AlexanderIYTClass II
K862792Mp-066 Radioaerosol KitMedipart Jerry AlexanderIYTClass II
K862791Mp-30Xm-Ie Face Mask and Filter KitMedipart Jerry AlexanderIYTClass II
K862790Mp-01X-I Disposable Filter KitMedipart Jerry AlexanderCAHClass II
K862789Mp-01X Disposable Bacteria Filter KitMedipart Jerry AlexanderCAHClass II
K862788Mp-4400 Mouthpiece-Flange SealMedipart Jerry AlexanderBYPClass I
K862787Mp-2831 Disposable Conductive Breathing FilterMedipart Jerry AlexanderCAHClass II
K862786Mp-50T Disposable Breathing Circuit FilterMedipart Jerry AlexanderCAHClass II
K862785Mp-1204 Disposable Bacteria FilterMedipart Jerry AlexanderCAHClass II
K862784Mp-Xmo Disposable Face MaskMedipart Jerry AlexanderBSJClass I
K862783Mp-Xmv Disposable Face MaskMedipart Jerry AlexanderBSJClass I
K862782Mp-Xml Disposable Face MaskMedipart Jerry AlexanderBSJClass I
K862781Mp-Xmm Disposable Face MaskMedipart Jerry AlexanderBSJClass I
K862754Custom in-the-Ear and Canal Hearing AidCochlear Laboratories, Ltd.ESDClass I
K862734Ceilstand, Multistand R & S and the BuckystandD&R X-Ray Products, Inc.IYBClass I
K862731Sta-Sof Breast Compressor-ClampSta-Sof, Inc.
K862726Disposable Shoe Covers and Nurses CapsAbco Dealers, Inc.FXPClass I
K862725Saccomanno Speciman SolutionMill-Rose LaboratoryLDZClass I
K862709Mechanical CystitomeRudolph Beaver, Inc.HNYClass I
K862666Uncuffed Laser Resisteant Tracheal Tube(tentative)Mallinckrodt Critical CareBTRClass II
K862627Sonoranger Transvaginal ProbeAusonics Pty, Ltd.HEMClass II
K862624I81 CiteOticon, Inc.ERAClass I
K862622I22 CiteOticon, Inc.ESDClass I