510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2791 of 3530
510(k) clearances, page 2791 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K872458An3200 Doubilet DrainH.W. Andersen Products, Inc.FGEClass II
K873251Omnifit Bone ScrewOsteonics Corp.HWCClass II
K873247Csf-Flow Control Valve, Ultra SmallPudenz-Schulte Medical Research Corp.JXGClass II
K873232Brain Heart Infusion Agar - Bhia Product #P3302Lakewood Biochemical Co., Inc.JSGClass I
K873231Brain Heart Infusion Agar W/gentamicin - #P3704Lakewood Biochemical Co., Inc.JSJClass I
K873230Brain Heart Infusion Agar IV - Product #P3591Lakewood Biochemical Co., Inc.JSJClass I
K873229Brain Heart Infusion Agar III - Product #P3590Lakewood Biochemical Co., Inc.JSJClass I
K872862Prl Serozyme Immunoenz. Assay Kit, Mag. Solid PhasSerono Diagnostics, Inc.CFTClass I
K872737Perkin-Elmer Lc235 Diode Array DetectorRevvity Health Sciences, Inc.
K872701Respiratory Syncytial Virus Cf Antigen & ControlSita, Inc.LKTClass I
K872699Mumps Cf Antigen and Control AntigenSita, Inc.GRBClass I
K872698Adenovirus Cf Antigen and Control AntigenSita, Inc.GOAClass I
K872697Parainfluenza-I-Cf Antigen and Control AntigenSita, Inc.GQTClass I
K872696Parainfluenza-3-Cf Antigen and Control AntigenSita, Inc.GQTClass I
K872695Parainfluenza-2-Cf Antigen and Control AntigenSita, Inc.GQTClass I
K872694Ynfluenza a Virus Cf Antigen and Control AntigenSita, Inc.GNWClass I
K872693Influenza B Virus Cf Antigen and Control AntigenSita, Inc.GNWClass I
K872639Deluxe Motorized Treadmill Model #Ft2300Invacare GmbHBXBClass I
K872638Motorized Treadmill Model #Ft2200Invacare GmbHBXBClass I
K872586Ergometric Motorized Treadmill Model #Ft2400Invacare GmbHBXBClass I
K872368Modified Versa Stim Electrode LineConmedcorpDROClass II
K872051Calcium CalibratorFUJIFILM Healthcare Americas CorporationJISClass II
K872034Cardiomedics External Counterpulsation SystemCardiomedics, Inc.DRNClass II
K871653Duraphase Penile ProsthesisDacomed Corp.FAEClass II
K873277Mitraflex(tm) Wound DressingMatrix Medica, Inc.NADClass I
K873276Extension Device 1416Stierlen-Maquet AGJEBClass I
K873275Extension Table 1417Stierlen-Maquet AGJEBClass I
K873274Plaster Table 1418Stierlen-Maquet AGJEBClass I
K873273Orthopaedic Table 1420Stierlen-Maquet AGJEBClass I
K872992Sps Suspension Enema KitCarolina Medical Products Co.FCEClass I
K872164RestoreAnderson Research, Inc.LPNClass II
K873507Link (R) American-Type Bone Staple SystemLink America, Inc.JDRClass II
K873484120Z(tens)Oms Medico, Inc.GZJClass II
K873299Merifluor(tm)-GiardiaMeridian Diagnostics, Inc.GWDClass II
K873189Hearing Aid (All-in-the-Ear)Sight-N-Sound & Co.ESDClass I
K873169Dahlberg Model Gh Body AidDahlberg Electronics, Inc.ESDClass I
K873153Caulk's Vps Cartridge SystemDentsply Intl.EIDClass I
K873139Varus and Valgus Leg HolderLeonard Medical, Inc.FWZClass I
K873134Unifast Ck-MbSclavo, Inc.CGSClass II
K873105Reflo-Chex, a Cholesterol Reference ControlStreck Laboratories, Inc.JJXClass I
K873089Precision Hip Long Stem Femoral Component SystemHowmedica Corp.JDGClass II
K873030Concept Arthroscopic Portal RodConcept, Inc.HRXClass II
K872995Hearing Aid (All in the Ear)Sound Crafters Hearing InstrumentsESDClass I
K872988Transigen Exudate Controlled Wound DressingSmith & Nephew, Inc.NADClass I
K872977Hearing Aid (All-in-the-Ear)The Hour GlassESDClass I
K872951American Brain Retractor CoverAmerican Silk Sutures, Inc.GETClass I
K872922In the Ear Hearing AidAudio Hearing Aid ServiceESDClass I
K872891Lactate Dehydrogenase Isoenzyme 1Data Medical Associates, Inc.CEXClass II
K872749Spectrophotometers Models:abc+,abc,s 500, S 1000Secomam Co.JJQClass I
K872633Master-Fit Hearing Evalua. & Recom. (Hear) SystemHearing Health Care ProgramETWClass II