510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2086 of 3531
510(k) clearances, page 2086 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K943466Mini S.f.t. (Urine Preservative)Cambridge Diagnostic Products, Inc.LXGClass I
K943419Orthodontic Elastomeric Lagature ModuleJon-Ko Products, Inc.ECIClass I
K941066Dental 911L.A.F. Industries, Inc.EMBClass I
K940317SinuscopeStephen Chakoff, Inc.EOBClass II
K935877Nihon Kohden Central Nurse Station, Cns-8310A/cns-8350ANihon Kohden America IncDSIClass II
K934939Temporary Screening Lead/ Catheter KitMedtronic, Inc.MAJClass II
K926496Sil-Slip (Coated/regular(non-Coated)thoracic DrainSil-Med Corp.GBXClass I
K951985Precision Bipolar CoagulatorValley Forge Scientific Corp.GEIClass II
K951867Permaquik Bonding PrimerUltradent Products Inc.KLEClass II
K951864Prime & Bond Direct Composite Bonding AgentDentsply Intl.KLEClass II
K951776Band SeaterOrmco Corp.ECRClass I
K951555Fuji IXGC America Inc.EMAClass II
K951515Monoject Vertical Entry Chemotherapy Sharps ContainerSherwood Medical Co.FMIClass II
K951476E-Pack Procedure KitsEthicon, IncMCYClass II
K951238Safe-Tips EzSafe Wave Products, Inc.EIAClass I
K950629Access Allergens - Fematophagoides Farinae, Cat Dander, Timothy Grass, and Alternaria Alternata Which Are Specific IgezrBio-Rad Laboratories Inc.DHBClass II
K950410Conair Body and SoleConair LLC.IROClass I
K950299Cerec 2KaVo Dental Technologies, LLCELWClass II
K950284Sims Deltec, Inc. Catheter Replacement ConnectorSims Deltec, Inc.FOZClass II
K946165Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemElekta Instruments, Inc.HRSClass II
K945728Catco Thoracic CatheterCatco Medical, Inc.JOLClass II
K945542Altra Flux(tm) 170 HemodialyzerAlthin Medical AB an Affiliate of Baxter IntlKDIClass II
K945267Optus Arthroscopes and Mini-ArthroscopesOptus, Inc.HRXClass II
K944190Lifecare 175 Infuser, ModificationAbbott MedicalFRNClass II
K944094TriadyneKCI USA, Inc.FNMClass II
K943421Orthodonitc Elastomeric SleevingJon-Ko Products, Inc.DZDClass I
K943420Orthodontic Elastomeric ChainJon-Ko Products, Inc.ECIClass I
K943418Orthodontic Elastomeric Separator ModuleJon-Ko Products, Inc.ECIClass I
K943417Orthodontic Elastomeric Tube/threadJon-Ko Products, Inc.ECIClass I
K943394Prostat ControlQuantimetrix Corp.JJYClass I
K942881Tc 3000Gaymar Industries, Inc.DWJClass II
K942428Cmt-1000Ems, Inc.LIHClass II
K940179Arthroscope for Small Joint After Feldkamp, Model 8871.011Richard Wolf Medical Instruments Corp.HRXClass II
K935842Rusch Lasertubus/rusch Laser Resistant Cuffed with Murphy EyeRusch, Inc.BTRClass II
K933524Extention SetMediziv Medical Products 1987, Ltd.FPKClass II
K925433The Stachrom Heparin Assay KitAmerican Bioproducts Co.KFFClass II
K952022Prima Volumn VentilatorssPrima, Inc.BZOClass I
K952021Prima Hyuperinflation SystemPrima, Inc.BZRClass II
K952020Prima Pediatric Anesthesia CircuitsPrima, Inc.CAIClass I
K952019Prima Adult Gas Sampling CircuitsPrima, Inc.CAIClass I
K952018Prima Coaxial CircuitsPrima, Inc.CAIClass I
K952017Prima Mapleson D CircuitPrima, Inc.CAIClass I
K952016Prima Pediatric Gas Sampling CircuitsPrima, Inc.CAIClass I
K952015Prima FilterPrima, Inc.CAHClass II
K952014Prima Adult Temperature Monitoring Anesthesia CircuitsPrima, Inc.CAIClass I
K952013Prima Guedel AirwaysPrima, Inc.BTRClass II
K952012Prima Custom Anestesia CircuitPrima, Inc.BZOClass I
K952011Prima Breathing BagsPrima, Inc.BZOClass I
K952010Prima Ventilator HosesPrima, Inc.BZOClass I
K951697Pediatric Endotracheal TubeUnomedical Sdn BhdBTRClass II