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 3222 of 3528
510(k) clearances, page 3222 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821381IOL ForcepsCilco, Inc.KYBClass I
K821192Ysi #24 & 24M Glucose AnalyzersYellow Springs Instrument Co., Inc.CGAClass II
K821107ExophthalmometerMedical Equipment Designs, Inc.HCSClass II
K821084Universal Trial FrameeMedical Equipment Designs, Inc.HPAClass I
K821083P.d. MeterMedical Equipment Designs, Inc.HLHClass I
K821082Trial Lens SetMedical Equipment Designs, Inc.HLHClass I
K821081Chart ProjectorMedical Equipment Designs, Inc.HOJClass I
K820933Cilco I/a HandpieceCilco, Inc.HQEClass II
K820375Plastic or Glass MagnifierGazelle Corp.HJFClass I
K827506Model Ml-820 Carbon Dioxide Laser System for SurgeryMerrimack Laboratories
K827470Stationary Special Purpose Podiatry X-Ray UnitFranklin X-Ray Corp.
K821647Foam WedgesFred Sammons, Inc.
K821646Tiny Flex-Glass, Set of 4Fred Sammons, Inc.IKWClass I
K821645Back SkpportsFred Sammons, Inc.IPTClass I
K821644Vacuum Wand and Uni-ReaderFred Sammons, Inc.ILPClass I
K821643Eating UtensilsFred Sammons, Inc.ILCClass I
K821642Wheel Chair AccessoriesFred Sammons, Inc.KNOClass I
K821641ObthosesFred Sammons, Inc.IQIClass I
K821640Orthotic Fabrication AccessoriesFred Sammons, Inc.IQIClass I
K821639Ankle Foot OrthosisFred Sammons, Inc.ITWClass I
K821638Hygiene AdaptorsFred Sammons, Inc.ILSClass I
K821637Wire-Foam Mp Flexion SpringFred Sammons, Inc.ILHClass I
K821636Attach-a-PakFred Sammons, Inc.IMEClass I
K821635Soft Ulnar Deviation SplintsFred Sammons, Inc.ILHClass I
K821634Ez Stand Mobile StoolFred Sammons, Inc.IMMClass I
K821633Variable Speed Vibrator, 120V 83-117 VibFred Sammons, Inc.IROClass I
K821631Pinch Gauge, 0-301 Lbs.Fred Sammons, Inc.HRWClass I
K821562Lancer Msa Bun Diag. KitSherwood Medical Co.CDQClass II
K821552Preg-KnowImmuno Pathology LabsJHJClass II
K821545Tandem Prolactin KitHybritech, Inc.CFTClass I
K821531Emit Timer Unit #100Syva Co.JQPClass I
K821310Espree' Anesthesia Bacterial FilterEsp Plastics, Inc.CAHClass II
K820978Ventre/spec Allergen Control-InhalantVentrex Laboratories, Inc.DGCClass II
K820977Ventre/spec Allergen Control-Molds/foodVentrex Laboratories, Inc.DGCClass II
K820938Hawkins Electrokinetic Body ActivatingLeisure WayIPFClass II
K821615Vast Ventrex Pd Ige Ria Test SetVentrex Laboratories, Inc.DGCClass II
K821582Warm'n Form Sports SupportsJerome MedicalIQIClass I
K821576Antinuclear Antibody Screen FlourescImmuno-Products IndustriesDBLClass II
K821574Eosin Y Solutin, AgueousSigma Chemical Co.HYBClass I
K821544Detection of TheophyllineElectro-Nucleonics Laboratories, Inc.KLSClass II
K821541Hematoxylin IIIVolu Sol Medical IndustriesHYJClass I
K821540Hematoxylin IIVolu Sol Medical IndustriesHYJClass I
K821534Hematology Data Management SysBiovation, Inc.JGPClass II
K821533Hematoxylin IVolu Sol Medical IndustriesHYJClass I
K821526Acid Phosphatase Reagent SetAnco Medical Reagents & Assoc.CKEClass II
K821517Titanan Gel Serum Protein ElectrophoresHelena Laboratories, Corp.JJNClass I
K821485DermabradersSpire Medical, Inc.GFFClass I
K821483Il 1302 Ph Blood Gas AnalyzerInstrumentation Laboratory Co.CHLClass II
K821366Tandem - Hgh KitHybritech, Inc.CFLClass I
K821348Hypodermic Needles & SyringesMedi-Tech, Inc.GAAClass I