510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2830 of 3529
510(k) clearances, page 2830 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K870994Abuscreen Radioimmunoassay for BenzodiazepinesRoche Diagnostic Systems, Inc.JXMClass II
K870931Tina-Quant(r) (a) C4Boehringer Mannheim Corp.DBIClass II
K870930Tina-Quant(r) (a) C3Boehringer Mannheim Corp.CZMClass II
K870862Spq(tm) Test System for Apolipoprotein AlAtlantic AntibodiesMSJClass I
K870811Model 102 Ph MeterMesa Medical, Inc.LRIClass II
K870624Ventrex Ip Specific E Enzyme ImmunoassayVentrex Laboratories, Inc.DHBClass II
K870564Spq(tm) Test System for Apolipoprotein BAtlantic AntibodiesMSJClass I
K870469Defined Equine Serum #a-3311Hyclone Laboratories, Inc.KISClass I
K870468Adult Bovine SerumHyclone Laboratories, Inc.KISClass I
K870467Defined Calf Bovine Serum Supplemented #a-2151Hyclone Laboratories, Inc.KISClass I
K870466Defined Calf Bovine Serum #a-2111Hyclone Laboratories, Inc.KISClass I
K8704656/40 Fetal Bovine Serum #a-1110Hyclone Laboratories, Inc.KISClass I
K870464Characterized Fetal Bovine Serum #a-1115Hyclone Laboratories, Inc.KISClass I
K870463Defined Fetal Bovine Serum #a-1111Hyclone Laboratories, Inc.KISClass I
K870453Ds-DNA Eia Diagnostic KitBiohytech International, Inc.LJMClass II
K870425Auto Entry System (Mate)Kg Engineering, Inc.IORClass I
K864857Opti-Fix Acetabular ComponentRichards Medical Co., Inc.JDIClass II
K871087S.c.m.t. PerforatorSalt Creek Medical TechnologiesHGEClass I
K871076WinpetteUlster Scientific, Inc.JPHClass I
K871075Scmt Umbilical ClampSalt Creek Medical TechnologiesHFWClass II
K871035'Exmoor' T-TubeExmoor Plastics LimitedETDClass II
K870901Mt8 Biological Telemetry SystemOxford Metrics, Inc.
K87088245 Degree ShaverBowen & Company, Inc.HTZClass I
K870881Loose Body GraspersBowen & Company, Inc.HTDClass I
K870872Discipline IPhysio Systems, Inc.ISDClass II
K870834Tdk ECG Electrode Mel-10Tdk Corp.DRXClass II
K870826Additional Letter Designation for Aortic Arch Can.Shiley, Inc.DQRClass II
K870825New Model Styles for Aortic Arch CannulaShiley, Inc.DQRClass II
K870663Api Uniscept(r) Micro-Mic(r) System/uniscept(r)micAnalytical Products, Inc.JWYClass II
K870599Tip, Dental Suction ApparatusMilitary Engineering, Inc.DYNClass I
K870554Cassette Tape Replay SystemResearch Instrumentation Associates, Inc.DSHClass II
K864938'Exmoor' Moffat-Robinson Bone Pate CollectorExmoor Plastics LimitedLRCClass I
K864293Heart TrackCardio Telemetric Systems, Inc.DXHClass II
K8637087.5 Mhz Sector Probe Model #Gm-0317Ss12Siemens Medical Solutions USA, Inc.ITXClass II
K863424Computer Eye Tracking Sys./eng Exam. Chair & TableMicromedical Technologies, Inc.GWNClass II
K862427Modified Drager SphygmomedDraeger, Inc.DXNClass II
K870902Look Retrobulbar NeedlesLook, Inc.HMXClass I
K870851Edec 80 Constant Potential X-Ray GeneratorElectromed Intl., Ltd.IZOClass I
K870824Additional Cardiac Pacing Leads #1020 Through 1035Pacesetter SystemsDTBClass III
K870823Emit Nortriptyline AssaySyva Co.LFGClass II
K870723Heartech Hfx, Hearing AidHearing Tech, Inc.ESDClass I
K870621Satlite/pb251 Pulse OximeterDatex Division Instrumentarium Corp.DQAClass II
K870610Resubmission of Model 030-437 Implant. ElectrodeTelectronics, Inc.DTBClass III
K870559Iodosorb PowderPerstorp AB C/O Robert Joel SlomoffKOZClass I
K870445Threaded Acetabular ComponentJohnson & Johnson Professionals, Inc.JDIClass II
K870373Sterile Procedural TraysDimed, Intl.KDDClass I
K870234P.t.h. Metal-Backed Acetabular CupOrthopaedic Device Corp.JDLClass III
K870216Microstructured Spherical Acetabular ComponentsOsteonics Corp.JDIClass II
K870117Neisseria/branhamella Differential TestPro-Lab, Inc.JSXClass I
K864924Kirschner (R) Small Fragment Fixation SystemKirschner Medical Corp.HRSClass II