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 3226 of 3528
510(k) clearances, page 3226 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821290Littauer Scissors 5 1/2Conphar, Inc.HNFClass I
K821286Iris Scissors Straight 4 1/2Conphar, Inc.HNFClass I
K821285Splinter Forceps 4 1/2Conphar, Inc.EFLClass I
K821284Adson Forceps 4 3/4Conphar, Inc.EFLClass I
K821282Thumb Dressing Forceps 5Conphar, Inc.EFLClass I
K821276Mayo Scissor Curyed 5 1/2Conphar, Inc.EGNClass I
K821275Mayo Scissor Straight 5 1/2Conphar, Inc.EGNClass I
K821273Mayo Scissor Straight 6 3/4Conphar, Inc.EGMClass II
K821248Rochester Pean ForcepsConphar, Inc.GENClass I
K821238Cc-700 Seven Parameter, Automated HemaaDysmexGKLClass II
K821230Softic 49The Healthcare Group Laboratories, Inc.EBIClass II
K821219Series 4 Liquid ChromatographRevvity Health Sciences, Inc.LDMClass I
K821144Ohio AbsorberOhio Medical ProductsBSFClass I
K821033Coratomic Model Ovalith-920Coratomic, Inc.DXYClass III
K821014Coratomic Model Ovalith 920BpCoratomic, Inc.DXYClass III
K821012H-H Alimentation CathetersHolter-Hausner Intl.LFJClass II
K820837Disposable Multiple Ligating ClipEthicon, IncGDOClass I
K820564World's Best (Contraceptive)Rosen Kilde StenhojHISClass II
K821569Leather ValvulotomeAmerican V. MuellerDWSClass I
K821495Disposable Blood Line ConnectorsBentley Laboratories, Inc.KOCClass II
K821436Electronic Digital ThermometerTimex Medical Products Corp.FLLClass II
K821415Model 90 BcWestern Laboratories Corp.FLBClass II
K821414Model 80 BcWestern Laboratories Corp.
K821361Conphar Tonsil ScissorsConphar, Inc.FZTClass I
K821359Arthroscopes & Associated InstrumentsDowns Surgical, Ltd.HRXClass II
K821355Conphar Littauer ScissorsConphar, Inc.FZTClass I
K821353Conphar Allis ForcepsConphar, Inc.GENClass I
K821352Conphar Iris ScissorsConphar, Inc.FZTClass I
K821351Conphar Dissecting ScissorsConphar, Inc.FZTClass I
K821350Conphar Wire Cutting ScissorsConphar, Inc.FZTClass I
K821340Variaxial Constrained Total Knee Prosth.Intermedics OrthopedicsKROClass II
K821339Salmonella PolyAnalytical Products, Inc.GENClass I
K821332Dustcovers &/or Sterility Maint. CoversMedical Industries Packaging, Inc.KCTClass II
K821296Rochester Pean Forceps Curved 6 1/4Conphar, Inc.GENClass I
K821287Crile Forceps Straight 5 1/2Conphar, Inc.GENClass I
K821283Hartman Forceps (Mosquito)Conphar, Inc.GENClass I
K821281Crile, Curved Forceps 5 1/2Conphar, Inc.GENClass I
K821280Tissue ForcepsConphar, Inc.GENClass I
K821279Halstead Forceps (Mosquito) 5Conphar, Inc.GENClass I
K821278Hartman Forceps Straight 3 1/2Conphar, Inc.GENClass I
K821277Kelly Forceps Curved 5 1/2Conphar, Inc.GENClass I
K821274Halstead Mosquito ForcepsConphar, Inc.GENClass I
K821269Tracheostomy Care TraysIntermed, Inc.EQNClass II
K821267Thumb Dressing ForcepsConphar, Inc.GENClass I
K821187Medco Custom Ear Protector Mold KitSanta Barbara Medco, Inc.EWDUnclassified
K821160Pneumo Drain T.m. Recorder #Pd-800Sugen Industries, Inc.GCXClass II
K821038Fast Violet BDms LaboratoriesJTSClass I
K820002Bard Contour Link S.k.i. Knee SysC.R. Bard IncHRYClass II
K821453Cardiocassette II #363Birtcher Corp.DSHClass II
K821450Pressure Tubing-Adult & PediatricGould, Inc.DRSClass II