510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3342 of 3526
510(k) clearances, page 3342 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K801743Plastazote ShoeAlimed, LLCKNPClass I
K801732Prisma-FilDentsply Intl.EBFClass II
K801724Curity Paracervical/pudendal Block AnesThe Kendal Co.CAZClass II
K801714Trans Distal Joint Finger Exten. SplintFred Sammons, Inc.ILHClass I
K801713Bk-6157-02 C.v.a Sling, Medium&largeFred Sammons, Inc.ILIClass I
K801712Lumbosacral Supports & Thoraco-Lumbo-SacFred Sammons, Inc.IPYClass I
K801710Bk-5315-01 Foam Hand Exerciser, SmallFred Sammons, Inc.IONClass I
K801709Bk-5058-01 Quad-Quip Wheelchair CuffFred Sammons, Inc.KNOClass I
K801708Bk-1520-01 Economy Wrist Support, ChildFred Sammons, Inc.IQIClass I
K801706Bk-1426-00-01 Stonybrook/hi-Wall PlateFred Sammons, Inc.ILCClass I
K801705Bk-1424 Inner Lip Plate, CeramicFred Sammons, Inc.ILCClass I
K801701Bauer & Black Rigid Wrist BraceBD Becton Dickinson Vacutainer Systems PreanalyticIQIClass I
K801700Uni-Record IBD Becton Dickinson Vacutainer Systems PreanalyticDXHClass II
K801697Model Bp-200 Infant Pressure VentilatorBourns Medical Systems, Inc.CBKClass II
K801677Electrocardiograph, Model ECG-5503Nihon Kohden America IncDPSClass II
K801628Restraint, ProtectiveThe Owenby Co.IQKClass I
K801607Mom 2Neotronics, Inc.CCLClass II
K801365Kold WrapRomaine, Inc.IMEClass I
K801349Loseff Balloon Type Self-Retention WoundLoseff Medical Designers, Ltd.JCXClass II
K801142Palodent Matrices & Bitine RingsAlvin Meyer, D.D.S.DZNClass I
K801065Nikkiso Parallel Flow DialyzersInt'L Marketing & Sales Corp.FTGClass II
K800536Model H 607-.67M2 30 Micron Rp An69 MemHospal Medical Corp.KDIClass II
K801719Bk-7531 Pain Threshold/finger Force GaugFred Sammons, Inc.HRWClass I
K801718Bk-7513 Stainless Steel GoniometerFred Sammons, Inc.KQWClass I
K801717Bk-7511 Brass GoniometerFred Sammons, Inc.KQWClass I
K801716Bk-7505 Radiopaque Goniometer, 8Fred Sammons, Inc.KQWClass I
K801715Bk-7497 Bulb DynamometerFred Sammons, Inc.KQWClass I
K801688Torx Handpiece Contra Angles AttachmentsPacific Dental Corp.EGSClass I
K801687Torx Micro-Motor Low Speed HandpiecePacific Dental Corp.EKXClass I
K801686Spaceline Three Way SyringePacific Dental Corp.ECBClass I
K801685Spaceline Dental Chair-UnitPacific Dental Corp.EIAClass I
K801684Astron Air Powered High Speed De PiecePacific Dental Corp.
K801683Luna-Vue Dental Operating LightPacific Dental Corp.EAZClass I
K801682Spaceline High Volume Evacuation HandpiePacific Dental Corp.EHZClass I
K801680Beta-Cap II AdapterQuinton, Inc.GCEClass I
K801671Esg-1 (Evoked Response Stimulus Gener)Neurodiagnostics, Inc.GWEClass II
K801670Ndi-Ike EMGNeurodiagnostics, Inc.GWKClass II
K801650Deseret Embolectomy/thrombectomy Cath.Deseret Medical, Inc.DXEClass II
K801635Biobrane Brand Temporary Wound-DressingHall-Woodroof, Inc.FROUnclassified
K801632The Bellco Fistula NeedlesBellco Artifidial Organ Spec., Inc.FIEClass II
K801619Mist2gen Temptrol 10Mistogen Equipment Co.BTTClass II
K801617Conductive Shoe CoversProcter & Gamble Mfg. Co.FXPClass I
K801616Non-Conductive Shoe CoversProcter & Gamble Mfg. Co.FXPClass I
K801612Frazier-Ferguson Suction Tubes (Disp.)Edward Weck, Inc.GCYClass I
K801611Deep Balfour Blade for Wilkinson RetractEdward Weck, Inc.GADClass I
K801610Children's Hospital Pediatric RetractorEdward Weck, Inc.GCZClass I
K801604Pathfinder Electrodiagnostic SystemNicolet Biomedical InstrumentsGWKClass II
K801597Pft CalibratorSpital Medical, Inc.BZCClass II
K801590Auto Suture Disposable Gia Surg. StaplerUnited States Surgical, A Division of Tyco HealthcFHMClass I
K801589Auto Suture Disp. 30, Etc. & Surg. StapUnited States Surgical, A Division of Tyco HealthcFHMClass I