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 2744 of 3530
510(k) clearances, page 2744 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K880254Sm Antibody Test KitLipogen, Inc.LKPClass II
K875300Medela Breast-Pump LactinaMedela AGHGXClass II
K875171J-Cath(tm)Hdc Corp.KNTClass II
K874755Effner Fe-Ex* OrogastricEffner and Spreine Co.KNTClass II
K874717Quidel Allergy ScreenOrtho-Clinical Diagnostics, Inc.DHBClass II
K874399Safecon CondomsQuality Synthetics Intl, Inc.HISClass II
K872356Condoms (Hombre Black/black Satin/xt-12/Orion)Mayer LaboratoriesHISClass II
K881287Animal and Human SeraCell Culture LaboratoriesKISClass I
K881282XyleneAnatech, Ltd.KEMClass I
K881254Statspin Disposable Rotor, Product #Rd01Norfolk Scientific, Inc.JQCClass I
K881159I.m.a. RetractorT. Korossurgical Instruments Corp.GADClass I
K881156Universal Sternum Spreader and I.m.a. RetractorT. Korossurgical Instruments Corp.GADClass I
K881069Disposable Sterile Latex Surgical GlovesKomin Trading Co.KGOClass I
K880949Single Reagent Calcium for Demand AnalyzerAdvanced Biomedical Methods, Inc.CJYClass II
K880845Calcium Reagent SetTech-Neal Scientific, Inc.CICClass II
K880844Albumin Reagent SetTech-Neal Scientific, Inc.CIXClass II
K880843Creatinine Reagent Set (Kinetic)Tech-Neal Scientific, Inc.CGXClass II
K880842Ldh-L Reagent SetTech-Neal Scientific, Inc.CFJClass II
K880743Abbott a-Gent Neonatal Bilirubin ReagentAbbott MedicalCIGClass II
K880678Modified Ventrescreen Beta Hcg Enzyme ImmunoassayVentrex Laboratories, Inc.DHAClass II
K880535Profect Surgeons' GlovesNetwork Trading Corp.KGOClass I
K880512Drug Mixture Control in UrineEastern Laboratories, Ltd.DIFClass I
K880445Lyphochek Urine Toxicology Control - LowBio-RadDIFClass I
K880410Human Chorionic Gonadotropin Visual Test KitDisease Detection International, Inc.JHIClass II
K880390Intraform Total Hip SystemOrthomet, Inc.JDIClass II
K880177Alkaline Phosphatase, Thymolphthalein MonophosphatTech-Co, Inc.CIOClass II
K880086Abbott Imx HtshAbbott MedicalJLWClass II
K875135Emit 700 Cannabinoid 100 Ng Calibrator & ControlSyva Co.DLJClass II
K875079Modified Seralyzer Alt/sgpt Reag. Strips & ModuleMiles Laboratories, Inc.CKAClass I
K874823First Response 5 Minute Pregnancy TestTambrands Inc.LCXClass II
K873428Glyco-Probe GspIsolab, Inc.LCPClass II
K881243Rubella Igg - Eia Test Kit Number 61 07 201Labsystems, Inc.LFXClass II
K881059Mct 8000 (Multi-Vision Contrast Tester)Vistech Consultants, Inc.HOXClass I
K880507Coulter Vcs Leukocyte Differential CounterCoulter Electronics, Inc.GKZClass II
K880471Bovine Calf Serum Supplemented #a-2159Hyclone Laboratories, Inc.KISClass I
K880377Novo Vivo Model #17140 and #17135Genesis Industries, Inc.GAAClass I
K881191Regal Latex Surgical GlovesMaxcare, Inc.KGOClass I
K881094Koi(tm) Blade Gauge, Model Koi-132CooperVision, Inc.HOEClass I
K881050Duoderm(r) CgfConvatec, A Division of E.R. Squibb & SonsNADClass I
K881023Vcts 6500 SystemVistech Consultants, Inc.HOXClass I
K881022Vcts Marketing Program SystemVistech Consultants, Inc.HOXClass I
K881021Vcts 700S SystemVistech Consultants, Inc.HOXClass I
K880950Pyr/esculin DiskRemel IncJTOClass I
K880947Nutrient Agar Plate, Slant Tube and Broth TubeLakewood Biochemical Co., Inc.JSGClass I
K880946Nutrient Gelatin - Product Number T2860Lakewood Biochemical Co., Inc.JSFClass I
K880855Parel Rare Earth Magnet, I.o.m., Intraocular MagRichard James, Inc.HPNClass I
K880788Non Adherent PadCederroth, Inc. USAFROUnclassified
K880709California Convertibles (Sunglasses)Jmj World Trade Corp.HQYClass I
K880675Easy Shield Adhesive BandageEye Garter Company, Inc.HOYClass I
K880647Adult Perceptual Motor Puzzles (5331-01)Fred Sammons, Inc.HOXClass I