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 |
|---|---|---|---|---|---|
| K233368 | Allograft Delivery Device (OFAC-C) | Bioventus LLC | FMF | Class II | |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec Inc | GZI | Class II | |
| K232640 | Venowave VW5 | Thermabright | JOW | Class II | |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical a/S | MWI | Class II | |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | WONTECH Co., Ltd. | GEX | Class II | |
| K241120 | Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. | OHT | Class II | |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28 | HSN | Class II | |
| K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 | Ambu A/S | FGB | Class II | |
| K233288 | NLZ Built-In Motor System | Nakanishi Inc. | EBW | Class I | |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | |
| K233123 | Silkro | Hironic Co., Ltd. | GEI | Class II | |
| K232952 | Copran Zri | Whitepeaks Dental Solutions GmbH | EIH | Class II | |
| K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | |
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte., Ltd. | ONB | Class II | |
| K241459 | MOTUS PRO Family | El.En S.p.A. | GEX | Class II | |
| K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte., Ltd. | KPE | Class II | |
| K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | QLQ | Class II | |
| K240862 | Medicom Sterilization Wrap | Medicom Group, Inc. | FRG | Class II | |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | QYT | Class II | |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FAJ | Class II | |
| K240649 | Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc | OWB | Class II | |
| K240387 | MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations, LLC | JOW | Class II | |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | JOW | Class II | |
| K234095 | OtoNova/OtoNova Pro | Otodynamics, Ltd. | EWO | Class II | |
| K233885 | rainbow Paste Stain SE | GENOSS Co., Ltd. | EIH | Class II | |
| K233876 | Unity Vcs (8065000296); Unity Cs (8065000297) | Alcon Laboratories | HQC | Class II | |
| K233549 | Tempus ECG-AF | TEMPUS AI, Inc. | SBQ | Class II | |
| K233361 | Sunny Cup and Applicator | Menstrual Mates, Inc | HHE | Class II | |
| K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | DQK | Class II | |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd | JXI | Class II | |
| K233280 | SteadyTemp | Steadysense GmbH | FLL | Class II | |
| K233259 | Xerosyn | Xerothera, Inc. | MQV | Class II | |
| K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd | QNL | Class II | |
| K233240 | GERDX-System | G-Surg GmbH | ODE | Class II | |
| K233230 | See Factor CT3™ | Epica International, Inc. | OWB | Class II | |
| K233196 | Medihub Prostate | JLK, Inc. | QIH | Class II | |
| K233096 | PRESSUREALERT® Pressure Monitoring System | Position Health, LLC | SBO | Class I | |
| K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Smith & Nephew, Inc. | MBI | Class II | |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Orthofix Medical, Inc. | MAX | Class II | |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI | Class II | |
| K240673 | Electric wheelchair | Zhejiang Hfizer Medical Equipment Co.,Ltd | ITI | Class II | |
| K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | Globus Medical, Inc. | JWH | Class II |