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 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242596 | Versalock Mini and Micro Plating System | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | PBX | Class II | |
| K242414 | TiLink-P Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K241495 | Jazz Classic | Jazz Imaging | LLZ | Class II | |
| K241319 | Skr 3000 | Konica Minolta, Inc. | MQB | Class II | |
| K241210 | Luja Coude | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K241157 | Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. | GEI | Class II | |
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty Ltd | CBF | Class II | |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH | Shenzhen Smallsignal Technology Co., Ltd. | DQA | Class II | |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | PBX | Class II | |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. | NGL | Class II | |
| K242521 | Estar-ZE | OSSTEM Implant Co., Ltd. | EIH | Class II | |
| K242520 | Element Vascular Access System | Penumbra Inc. | DYB | Class II | |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | OVE | Class II | |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OAP | Class II | |
| K242359 | Strain AI (SAI001) | Exo, Inc. | QIH | Class II | |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | Sol-Millennium Medical, Inc. | QNQ | Class II | |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | BZG | Class II | |
| K241603 | Powered Wheelchair (NXN20-208, NXN20-211) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | MBB | Class II | |
| K240746 | Neurovascular Access System Family | Q'apel Medical, Inc. | QJP | Class II | |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | PKC | Class II | |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | IRP | Class II | |
| K243323 | Iconix Knotless Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | MOS | Class II | |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics Inc. | JWH | Class II | |
| K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | JAQ | Class II | |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated | OMC | Class II | |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K242516 | EUROPA™ Posterior Cervical Fusion System | Mirus, LLC | NKG | Class II | |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | IYO | Class II | |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | |
| K242102 | CerroZone Mini | Cerrozone | FRF | Class II | |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | BTA | Class II | |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | CGX | Class II | |
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | PZI | Class II | |
| K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | MQV | Class II | |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K242471 | Power Wheelchair (W5538) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K242402 | Power wheelchair | Zhejiang Zhonglei Medical Technology Co., Ltd. | ITI | Class II | |
| K242329 | CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd. | LLZ | Class II | |
| K242092 | MICRO Arterial Filters | Corcym Inc. | DTM | Class II | |
| K241814 | da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K241747 | Saige-Dx | Deephealth | QDQ | Class II | |
| K241700 | Tenex 2nd Generation System | Trice Medical | LFL | Unclassified | |
| K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | QME | Class II | |
| K241498 | Diode laser Treatment System (K18) | Hebei Keylaser Sci-Tech Co., Ltd. | GEX | Class II | |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | MOF | Class II | |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II |