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 |
|---|---|---|---|---|---|
| K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | Fit-Pro KFT (Ltd.) - DBA E-Fit | |||
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | NKB | Class II | |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K262983 | EsTemp Implant | Spident Co., Ltd. | EMA | Class II | |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | HWC | Class II | |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | |
| K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | JKA | Class II | |
| K262196 | Invisalign System | Align Technology, Inc. | PNN | Class II | |
| K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | JOJ | Class II | |
| K261977 | Braun Aura 9 (6042) | Cyden Limited | OHT | Class II | |
| K261372 | Profoject™ LOR Syringe | CMT Health PTE., Ltd. | CAZ | Class II | |
| K261336 | Xpert Respiratory Panel | Cepheid | QOF | Class II | |
| K261262 | Altis Full Face Mask | Respironics, Inc. | BZD | Class II | |
| K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | PHZ | Class II | |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K260023 | TumorSight Risk | SimBioSys, Inc. | SHW | Class II | |
| K254297 | Tempus ECG-MR | Tempus AI, Inc. | SBQ | Class II | |
| K254291 | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | GDW | Class II | |
| K254255 | S-Patch CardioAI | Wellysis Corp. | DPS | Class II | |
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | HIH | Class II | |
| K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | QZF | Class II | |
| K254210 | Rebohil (Bgm-1, Bgm-2, Bgm-3, Bgm-4, Bgm-5) | Hyundai Bioland Co., Ltd. | NPM | Class II | |
| K254058 | DistaSense(TM) (v1) | Life Detection Technologies | DRT | Class II | |
| K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | GWF | Class II | |
| K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | PKC | Class II | |
| K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | MRW | Unclassified | |
| K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | KLE | Class II | |
| K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | OAP | Class II | |
| K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | PEN | Class II | |
| K262149 | corra® cervical plating system | Carlsmed, Inc. | KWQ | Class II | |
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | HSB | Class II | |
| K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | INI | Class II | |
| K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | MNR | Class II | |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | IYO | Class II | |
| K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | KFF | Class II | |
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K254303 | Karl Storz Supraloop | Karl Storz SE & CO. KG | KNF | Class II | |
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | GEX | Class II | |
| K263049 | SABER-C System | Elevation Spine | OVE | Class II | |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | ITI | Class II | |
| K262353 | Btl-299-F | BTL Industries, Inc. | KPI | Class II | |
| K262254 | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | OAP | Class II | |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | NHA | Class II | |
| K262156 | Anti-HCV Next | Abbott Laboratories | MZO | Class II | |
| K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | EFB | Class I | |
| K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | NKB | Class II | |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | HRS | Class II | |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | LLZ | Class II | |
| K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K261453 | G7® Acetabular System | Zimmer Biomet | LPH | Class II |