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 3217 of 3528
510(k) clearances, page 3217 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821189Multipurpose CatheterAdvanced Cardiovascular Systems, Inc.DQYClass II
K821188Introducer SetAdvanced Cardiovascular Systems, Inc.DYBClass II
K821090Cardi-O-Life Model 8823AmertekDPSClass II
K820887Mitral Valve Orifice SizerCeltechDTIClass I
K820727Cardiotomy ReservoirsErik Perfusion ServicesDTNClass II
K820600Hancock Vascular GraftExtracorporeal Medical Specialities, Inc.DSYClass II
K820524Clirans Hollow Fiber DialyzersTerumo Medical Corp.FJIClass II
K827455Sonoline 3000Siemens Medical Solutions USA, Inc.
K821867Ultrachem Gluc-DhHarleco DiagnosticsLFRClass II
K821862Quanticoat 125 I-Theophylline Radioimm.Kallestad Laboratories, Inc.LCAClass II
K821832Degucast UJ. Aderer, Inc.EJSClass II
K821824Tem-StikCoralite Dental Products, Inc.EMAClass II
K821810Piezon Ultrasonic ScalerHealthco, Inc.ELCClass II
K821791External Pulse Generator - Ev4542American Pacemaker Corp.DTEClass II
K821790Beach Excavator's No. 1 & No. 2Pacific Dental Corp.EKDClass I
K821789Beach Curette No. 2 and No. 3 T.g.Pacific Dental Corp.EMSClass I
K821788Beach Deriosteal Elevator, #2 StraightPacific Dental Corp.EMJClass I
K821787Beach Surgical Pliers Non-HookPacific Dental Corp.EJYClass I
K821786Beach ScalersPacific Dental Corp.EMNClass I
K821785Beach Amalgam CarverPacific Dental Corp.EKHClass I
K821784Beach Gingival Retraction Instr. Type BPacific Dental Corp.EIGClass I
K821783Beach Silicate Filling & Lining Applic.Pacific Dental Corp.
K821780Beach Explorer No. 23T.g.Pacific Dental Corp.EKBClass I
K821779Beach Amalgam Carrier, Gun TypePacific Dental Corp.EKJClass I
K821778Beach Dressing PlierPacific Dental Corp.EFLClass I
K821777Beach Mouth MirrorPacific Dental Corp.EAXClass I
K821738Clini-Tek Semi-Automated Urinalysis SystMiles Laboratories, Inc.KQOClass I
K821610Thioglycolate without IndicatorHardy MediaJSCClass I
K821609VagarHardy MediaJSHClass I
K821608Cna/vaginalis AgarHardy MediaJSIClass I
K821607Mueller Hinton W/5% Sheep's BloodHardy MediaJTZClass II
K821606Bile Esculin AgarHardy MediaJSFClass I
K821605Xylose Lysine Deoxycholate AgarHardy MediaJSIClass I
K821604Sabouraud's Dextrose (Sabdex)Hardy MediaJSGClass I
K821603Mycobiotic AgarHardy MediaJSJClass I
K821602Thayer MartinHardy MediaJTYClass II
K821601Tryptic Soy AgarHardy MediaJSCClass I
K821600Tryptic Soy BrothHardy MediaJSCClass I
K821599Gram Negative BrothHardy MediaJSJClass I
K821598Fluid Thioglycollate BrothHardy MediaJSCClass I
K813264D6zo Disposable Heat ExchangerElectromedics, Inc.DTRClass II
K827581Adac Model Dps-2800 Digital Processing SystemPhilips North America LLC
K827580Adac Model Dps-3300 Digital Processing SystemPhilips North America LLC
K827508Ultrasonic CleanerKeymed House
K827376Biopsy Guide Attachment for Use with Fetascan 800Cranbury Medical Labs, Inc.
K827375Biopsy Guide Attachment for Use with Fetascan 2000 and 2000ACranbury Medical Labs, Inc.
K821860Bk-6477 the Derby Raised Toilet SeatFred Sammons, Inc.ILSClass I
K821859Ortholace 4,5.6 EyeletFred Sammons, Inc.ILDClass I
K821858Notie Stretch-Lace-Various ModelsFred Sammons, Inc.ILDClass I
K821857Bk-5305 Multiple Hand GridFred Sammons, Inc.IONClass I