510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 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 2619 of 3530
510(k) clearances, page 2619 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K894278Storz Daisyplus Series Microsurgical SystemsStorz Instrument Co.HQEClass II
K894201Gomco Circumcision ClampZinnanti Surgical Instruments, Inc.HFXClass II
K894078Lyphochek(r) Tumor Marker Controls, Levels I & IIBio-RadJJYClass I
K894064Sterile Hand CoverSage Products LLCLYUClass I
K894043Spect.e.n.s Repositionable, Snap-Type, TENSLabeltape Meditect, Inc.GXYClass II
K894042Spect.e.n.s. Repositionable, Pin Type, TENSLabeltape Meditect, Inc.GXYClass II
K893995Dermacare Tie HolderDermacareKGSClass I
K893973Roche Reagent for TriglyceridesRoche Diagnostic Systems, Inc.CDTClass I
K893945Fd 350 Dental StoolOriola OY FinndentKLCClass I
K893875FlocareMega-Tech Intl., Inc.BYDClass I
K8938443D Dental Diamond Rotary InstrumentsLustgarten Multi-Tech International, Inc.DZPClass I
K893827Peak Flow Rate MeterLaytech Medical Co.FFGClass II
K893773Laurier Sanitary NapkinKao Corp.HHDClass I
K893738Quidel Reflectance AnalyzerOrtho-Clinical Diagnostics, Inc.JJQClass I
K893730Direct Bilirubin ReagentMedical Analysis Systems, Inc.CIGClass II
K893628Olympus Ise Module for Au5000Olympus Corp.CGZClass II
K893620T3 Clasp-Bead Eia KitBiotecx Laboratories, Inc.CDPClass II
K893509Ge Signa AdvantageGE HealthcareLNHClass II
K893507Innofluor Carbamazepine Reagent SetInnotron of Oregon, Inc.KLTClass II
K893379Xenos MobilecamXenos Medical Systems, Inc.IYXClass I
K892638Tracer Dynamic Axial FixationTracer MedicalJECClass II
K892473Patient Exam Gloves (Mfg. Ta Ta Industrial Co.)Mccampbell Ent. Unltd., Inc.LYYClass I
K891607DentanurseThe Irish SceneEMAClass II
K890446Anesthetic Gas MonitorBruel & Kjaer Instruments, Inc.CBSClass II
K880819CondomsUniversal Trade, Inc.HISClass II
K894689Penlon Idp Pressure Failure AlarmPenlon, Ltd.CAPClass II
K894670General Surgical InstrumentsNopa InstrumentsDXCClass II
K894574Technicon Dpa-1 System RF MethodTechnicon Instruments Corp.DHRClass II
K894573Scanlisa Human Crp Elisa KitImmuntech A/SDCKClass II
K894501Ammel Sterile Surgeon's GlovesMauricio MenconiKGOClass I
K894397Welcon Light HandleWelcon, Inc.FTAClass II
K894388Zimmer TENSAmerican ImexGZJClass II
K894311Modified Patient Examination GlovesSafeskin Corp.LYYClass I
K894211Sharplan Series 2900 Synthetic Contact TipsSharplan Lasers, Inc.GEXClass II
K894210Sharplan Series 2900 Synthetic Contact TipsSharplan Lasers, Inc.GEXClass II
K894066Sharplan CO2 Laparoscopic Probe Model 792 to 792BxSharplan Lasers, Inc.GEXClass II
K894002Cytomegalovirus Fluorescent Monoclonal AntibodyBaxter Healthcare CorporationLINClass II
K893956Eagle Laser, Surgical, Neodymium Doped YttriumLiving Technology, Inc.GEXClass II
K893883Powder Free Vinyl Examination GlovesLibent Co., Ltd.LYZClass I
K893814Surgical Instrument Kit, DisposableBiosealLROClass II
K893760Criterion i.v. Ventilator Breathing Circuit #1004Nova-VentrxBZOClass I
K893724Emas GloveExim Mfg. & Assoc. Services, Sdn BhdLYYClass I
K893699Patient Examination GlovesMarshall Latex Products Private, Ltd.LYYClass I
K893694Latex Exam Gloves(mfg: Shang Hai Rongtong Latex)Sinochem (USA), Inc.LYYClass I
K893651Surgicare (R) Latex Examination GlovesInter Continental Health CareLYYClass I
K893592Latex Examination GlovesExcel Glove Co., Ltd.LYYClass I
K893475Uroview IIOec-Diasonics, Inc.JAAClass II
K893464Varian Multileaf CollimatorVarian Assoc., Inc.IXIClass II
K893299Latex Examination GlovesWestmark Sps, Inc.LYYClass I
K893163Patient Examination GlovesNantong Ruchang Latex Products Co., Ltd.LYYClass I