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 3305 of 3528
510(k) clearances, page 3305 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810581Fact* Home Pregnancy TestOrtho Pharmaceutical Corp.JHJClass II
K810576Earette Hearing Aid(behing the Ear)Oticon, Inc.ESDClass I
K810575Martin Trach-SecureDiatek, Inc.BTOClass II
K810568Paraffin Embedding MediumSurgipath Medical Industries, Inc.KEOClass I
K810563Quinton Lte ElectrodeQuinton, Inc.DRXClass II
K810562Carbon Dioxide (C02) Microsurgical LaserMetricon, Ltd.HHRClass II
K810560Tn-3000 Evoked Response SystemTracor Northern, Inc.GWFClass II
K810559Opti- SystemCorpak Co.BTTClass II
K810558Skin Scrub TrayAssociated Medical Products Co.HFDClass II
K810548Cardiopulminary Bypass Catheter CannulaDlp, Inc.DWFClass II
K810541Beta Lysin DiskRemel Co.JTOClass I
K810539Model S10ctcm Auditory StimulatorGrass Instrument Co.GWJClass II
K810536Zeeman/5000 Graphite Furnace Atomic AbsbRevvity Health Sciences, Inc.JXRClass I
K810525Sr-Ivotray UniversalJ. Aderer, Inc.EHYClass I
K810524Sr-Ivotray SpecialJ. Aderer, Inc.EHYClass I
K810521Co-Span 13.5 Casting AlloyC.Vaupel Dental, Inc.EJHClass II
K810498Centric (Bite) Registration PasteWallace A. Erickson & Co.EFHClass I
K810495Stat Stain SetAccra Laboratories, Inc.IAFClass I
K810479SupportSci-Pharm, Inc.EBFClass II
K810415Sarns Two-State Wire Reinforced Catheter3M Health Care, SarnsDWFClass II
K810407Hydroxylate Enamel Bond SystemWallace A. Erickson & Co.KLEClass II
K810380Howmedica T-III G AlloyHowmedica Corp.EJSClass II
K810373Venturi Mask/delivery System #'STodd Industries, Inc.BYFClass I
K810362Corrugated Flex TubingTodd Industries, Inc.BYXClass I
K810361Connector AdaptersTodd Industries, Inc.BZAClass I
K810344Oxygen TubingTodd Industries, Inc.BYXClass I
K810343NebulizersTodd Industries, Inc.CCQClass I
K810342Nasal CannulaTodd Industries, Inc.CATClass I
K810341Lifeline Ippb Set-UpTodd Industries, Inc.BZOClass I
K810340Adult Masks & Pediatric MasksTodd Industries, Inc.BYGClass I
K810339Noseclip #6118Todd Industries, Inc.BXJClass I
K810252Stumark InfusorStumark Corp.FRNClass II
K810174Respiration Function BlocksHoneywell, Inc.BZQClass II
K810152X-VeeTemporaty Surgical SystemsHKPClass II
K803286CardiomemoInstromedix, Inc.KREClass II
K803081Quanticheck Control PlasmaAbbott MedicalGGQClass II
K810246EliteBloomex International, Inc.IPFClass II
K802804Nemectrodyn 8Nemectron Medical, Inc.IPFClass II
K810691Curity 100% Silicone Irrigation FoleyThe Kendal Co.EZLClass II
K810593Neuropac Ultra IMedical Devices Inc.GZJClass II
K810582Electrode, Pacemaker PermanentPacesetter SystemsDTBClass III
K810578Beckman Theophylline Reagent Test KitBeckman Instruments, Inc.KLSClass II
K810567Germco Test R Glucose Test KitFermco Biochemics, Inc.CGAClass II
K810557Hip Abduction SplintOrthomedicsIOZClass I
K810556Spinal Extension BraceOrthomedicsIPYClass I
K810555Scoliosis Orthotic SystemOrthomedicsIQFClass I
K810554Lumbar Flexion BraceOrthomedicsIPYClass I
K810542Cement Fume Evacuator Tank & FilterWalgen Medical InnoventionsJDYClass I
K810535Mouradian Modified Zickel Humeral RodHowmedica Corp.HSBClass II
K810512Mediseal Camera CoversJanin Group, Inc.KQMClass I