510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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
46,132 of the 176,529 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
20262,732
176,529 records, page 2102 of 3531
510(k) clearances, page 2102 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K945665Flexart(tm) Qd C-Spine CoilToshiba America Mri, Inc.LNHClass II
K945521Centermark(r) Picc Insertion Tray Landmark(r) Midline Catheter Prep TrayMenlo Care, Inc.FOZClass II
K941916Quest Coronary Sinus Perfusion Cannula -FrccQuest Medical, IncDWFClass II
K940298Bsc/ca Model 940 IabBoston Scientific CorporationDSPClass II
K935437Arbo H85v/h87v/h27v Dispos Monit ElectrodesArbo Medical, Inc.DRXClass II
K934975Telephone Electrocardiograph TransmitterRlt Medical Assoc., Inc.DXHClass II
K951129Novatrans IIMedex, Inc.DRSClass II
K950931Avon Massaging HairbrushSiegel,Mandell & Davidson,P.C.ISAClass I
K950904Orthofab Wheelchair Astra (Folding Manual Wheelchair)Orthofab, Inc.IORClass I
K950903Orthofab Wheelchair Ultima (Rigid Frame Manual Wheelchair)Orthofab, Inc.IORClass I
K950731Scimed 6 French Expo Angiographic CatheterScimed Life Systems, Inc.DQOClass II
K950510Octeia Igf-1 KitImmunodiagnostic Systems Ltd.CFLClass I
K950282Karl Storz Modified Veress Needle and CannulaKarl Storz Endoscopy-America, Inc.KOCClass II
K950181Urine Cannabinoids Screen Flex(tm) Reagent CartridgeE.I. Dupont de Nemours & Co., Inc.LDJClass II
K950156Acs Hi-Torque Extra S'port(tm) Guide WireAdvanced Cardiovascular Systems, Inc.DQXClass II
K950136Urine Opiates Screen Flex(tm) Reagent CartridgeE.I. Dupont de Nemours & Co., Inc.DJGClass II
K950117Persyst Spike DetectorPersyst Consulting Services, Inc.OMBClass II
K950096Pinworm Egg CollectorEvergreen Industries, Inc.LIOClass I
K950047Schneider Gex(tm) .014/.018 Guidewire Exchange CatheterIsomedix Operations IncDQYClass II
K950026Medtronic(r) 8.2 French Sherpa(r) Super Peak Flow(tm) Coronary Guiding CatheterMedtronics Interventional VascularDQYClass II
K946371Provident Hp SystemGlobus Medical, Inc.JDIClass II
K946197Consensus(tm) Patella ReamerU.S. Medical Products, Inc.HWEClass I
K945915Avl Omni AnalyzerAvl Scientific Corp.JJCClass I
K945913Irispec Urine Chemistry Control Part a and BInternational Remote Imaging SystemsJJWClass I
K945824Galaxy Md Series TherapypoolsGalaxy Aquatics, Inc.BXBClass I
K945187Roche Abuscreen Online for MethaqualoneRoche Diagnostic Systems, Inc.KXSClass II
K944614Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemBiosearch Medical Products, Inc.FDXClass II
K944410Catco Silicone Dual Lumen Umbilical Vessel CatheterCatco Medical, Inc.FOZClass II
K944368Catco Silicone Umbilical Vessel CatheterCatco Medical, Inc.FOZClass II
K944367Catco Polyurethane Umbilical Vessel CatheterCatco Medical, Inc.FOZClass II
K944336Catco Umbilical Vessel CatheterCatco Medical, Inc.FOZClass II
K942974Pyloriset DryOrion Diagnostica, Div. Orion Corp.LYRClass I
K941856Premier Promax Bite GuardPremier Dental Products CoJXLClass II
K940490Dv Test and Dvv ConfirmSekisui Diagnostics, LLCGIRClass I
K936056Hemdetect(r) Test for Occult Blood in FecesDipro Diagnostic Products GmbHKHEClass II
K935319Chemiluminescence LhNichols Institute DiagnosticsCEPClass I
K933200Olympus Pbd StentsOlympus Corp.FGEClass II
K951209SunglassesMainland WholesaleHQYClass I
K951066Rains Frontal Sinus StentSmith & Nephew Richards, Inc.KAMClass I
K950982B. Braun Sonocan Biopsy Needle and Aspiration HandleB. Braun of America, Inc.FCGClass II
K950461Welch Allyn OphthalmoscopeWelch Allyn IncHLIClass II
K950288Autolaser Multi Format CameraAfp Imaging Corp.LMCClass II
K950256Turbo 25/30Parkell, Inc.ELCClass II
K950240Le Clean MachineParkell, Inc.ELCClass II
K950033PolydermWilshire TechnologiesLZAClass I
K945911Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsBioclinical Systems, Inc.JTZClass II
K944092Additional Accessories for the Orthofix SystemOrthofix SRLJECClass II
K943931Carryall EnhancementsInstromedix, Inc.DXHClass II
K942361WhitsoftBiowhittaker Molecular Applications, Inc.JJQClass I
K942250Biowhittaker Cartridge Software for Eia-400 Plate ReaderBiowhittaker Molecular Applications, Inc.JJQClass I