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 2662 of 3530
510(k) clearances, page 2662 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891043Roto Fit Biopsy ForcepsZinnanti Surgical Instruments, Inc.HFBClass I
K891041Miya SpeculumZinnanti Surgical Instruments, Inc.HDFClass I
K891035Needle ExtensionsZinnanti Surgical Instruments, Inc.KOHClass I
K891032Endo Cervical Curette - Evans, Randall, GusbergZinnanti Surgical Instruments, Inc.HHTClass II
K890973Straight Paddle Surgical Cautery Electrode BladeInstrument Makar, Inc.JOSClass II
K890972Hook Tip Surgical Cautery Electrode BladeInstrument Makar, Inc.JOSClass II
K890820Locking Wire Guide StyletMedical Engineering and Development InstituteGADClass I
K890753Satlite Trans Portable Pulse OximeterDatex Division Instrumentarium Corp.DQAClass II
K890547Siemens Elema Models 4025 and 4026 AdaptersPacesetter SystemsDTBClass III
K890196Microtrak Chlamydia EiaSyva Co.LJCClass I
K890149Surgimax (Latex Exam Gloves)National Dental Supply, Inc.LYYClass I
K885328Rs-10 Telephonic Polysomnography ReceiverTelediagnostic Systems, Inc.GYEClass II
K885321Water Jel Sterile Gel-Soaked Burn DressingPfizer PharmaceuticalsFROUnclassified
K885292Cobas MfcRoche Diagnostic Systems, Inc.JQPClass I
K885283Aspirating and Irrigating Cysts NeedlesGo Medical Industries Pty., Ltd.GDMClass I
K885099Multiple (Sterile Surgical Towels)Med-Tex, Inc.KKXClass II
K885081Simrite Verification and Simulation SystemHaynes Radiation Ltd., Inc.KPQClass II
K884866Temp. Pacing Leads W/depth Markings Ta-1 and Tb-1Oscor Medical Corp.LDFClass II
K884657Lily i.v. SetModec Co., Inc.FPAClass II
K884631Flexible Endoscope 91-8200(90) and 91-82100(135)Xomed, Inc.LRCClass I
K891242Patient Examination Gloves (Latex)Dr. Boo Co., Ltd.LYYClass I
K891208Patient Examination Gloves (Latex)Cho FU Industrial Co., Ltd.LYYClass I
K891204Latex Examination GlovesAdvance Rubber, Inc.LYYClass I
K890849Hematastat H-70Separation Technology, Inc.GKGClass II
K890846Biotrol Urine Proteins ReagentBiotrol, USA, Inc.JIRClass I
K890768Pneumocystis Carinii Immunofluorescence Test KitGenetic Systems Corp.LYFClass II
K885245Cary-Blair Transport SystemPrecision Biologicals, Inc.JSMClass I
K885244Saf Fecal Collection KitPrecision Biologicals, Inc.JSMClass I
K890868Dma Microprotein ProcedureData Medical Associates, Inc.CEKClass II
K890708Amerlite Reproductive Endocrinology (Label Change)Amersham Corp.JJYClass I
K890011Oxygen Connector and Oxygen Delivery TubingLife Design Systems, Inc.BZOClass I
K8825089.5 French Percutaneous Double Lumen BalloonKontron Instruments, Inc.DSPClass II
K88227410.5 French Percutaneous Double Lumen Intra-AorticKontron Instruments, Inc.DSPClass II
K891126Microlase CO2 Laser MicromanipulatorXimed Medical SystemsGEXClass II
K891088Modified Labeling Packaging Sharplan 2100 SterileSharplan Lasers, Inc.GEXClass II
K891049Zeppelin ScissorsZinnanti Surgical Instruments, Inc.KOHClass I
K891047Zeppelin ForcepsZinnanti Surgical Instruments, Inc.HCZClass II
K891044Laser SpeculaZinnanti Surgical Instruments, Inc.HDFClass I
K891042Micro Surgery Needle HoldersZinnanti Surgical Instruments, Inc.KNAClass II
K891040Micro Surgery ScissorsZinnanti Surgical Instruments, Inc.KNAClass II
K891039Micro Surgery ForcepsZinnanti Surgical Instruments, Inc.KNAClass II
K891038Vaginal Retractors - Kristeller, Delee, BreiskyZinnanti Surgical Instruments, Inc.HDLClass I
K891037Weighted Specula-Steiner,henrotin,berland,garrigueZinnanti Surgical Instruments, Inc.HFDClass II
K891036Hysterectomy Forceps - (Several Models)Zinnanti Surgical Instruments, Inc.HCZClass II
K891034Tischler Biopsy ForcepsZinnanti Surgical Instruments, Inc.HFBClass I
K891033Atraumatic TenaculaZinnanti Surgical Instruments, Inc.HDCClass II
K891030IUD Hooks - Simple, Universal and SklarZinnanti Surgical Instruments, Inc.HHFClass I
K891029Cervical Dilators Pratt,hawkin,kleegman,denn.,vallZinnanti Surgical Instruments, Inc.HDQClass I
K891028Uterine Cannula - Kahn, Jarco, Corson, RatchetZinnanti Surgical Instruments, Inc.HIGClass II
K891027Zsi Biopsy ForcepsZinnanti Surgical Instruments, Inc.HFBClass I