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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K220573 | Noodle | Pourang Bral, DDS, LLC | NUH | Class II | |
| K221399 | ZIP™ MIS Interspinous Fusion System | Aurora Spine, Inc. | PEK | Class II | |
| K221346 | Stryker VariAx 2 MIS Calcaneus | Stryker Corp. | HRS | Class II | |
| K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Changsha Honchon Technology Co., Ltd | EIH | Class II | |
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations LLC | LZA | Class I | |
| K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets | HTL-Strefa S.A. | FMK | Class II | |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | JCT | Class II | |
| K220284 | Powder Free Nitrile Examination Gloves (Blue) | Kgm Gloves Sdn. Bhd. | LZA | Class I | |
| K213782 | Single-Use Video Bronchoscopes, Digital Controller | Micro-Tech (Nanjing) Co., Lts | EOQ | Class II | |
| K213009 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | IYN | Class II | |
| K212783 | ProstatID | Scanmed, LLC | QDQ | Class II | |
| K212775 | Adin Short Implants | Adin Dental Implants Systems, Ltd. | DZE | Class II | |
| K210793 | Vidas Nephrocheck | bioMerieux, Inc. | PIG | Class II | |
| K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | ELE | Class II | |
| K201440 | ROTEM sigma Thromboelastometry System | TEM Innovations GmbH | JPA | Class II | |
| K221679 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | OHT | Class II | |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | JOW | Class II | |
| K221293 | E-Brik Visualization Assistant | Jdi Surgical, Inc. | OCT | Class II | |
| K221246 | IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) | Shenzhen Semlamp Intelligent Technology Co., Ltd | OHT | Class II | |
| K220771 | Stratasys TrueDent | Stratasys Inc. | EBI | Class II | |
| K220534 | Wet Essential95 Personal Lubricant | Trigg Laboratories, Inc. | NUC | Class II | |
| K213873 | SkyWalker Total Knee System | MicroPort Navibot International LLC | OLO | Class II | |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical, LP | KWS | Class II | |
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | OLP | Class II | |
| K212472 | AgeJet | Triworks Group S.r.l. | GEI | Class II | |
| K221426 | Functional MR V1.0 | Olea Medical S.A.S. | LLZ | Class II | |
| K221173 | Surgical Mask (Model: 0868F, 0866F) | Jiangxi Sanhao Medical Instruments Co.,Ltd | FXX | Class II | |
| K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- und Composite Spezialitaten GmbH | KLE | Class II | |
| K221028 | SURGIVISIO Device | Ecential Robotics | OLO | Class II | |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-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) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | |
| K220024 | ChoiceSpine Navigation System | Choice Spine LLC | OLO | Class II | |
| K214038 | Oscar Peripheral Multifunctional Catheter system | BIOTRONIK AG | LIT | Class II | |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems Inc | OCC | Class II | |
| K213007 | Cerebra Sleep System | Cerebra Medical, Ltd. | OLV | Class II | |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | FCG | Class II | |
| K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | KNW | Class II | |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | FCG | Class II | |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | LPH | Class II | |
| K210069 | Minuteful - kidney test | Healthy.io Ltd. | JIR | Class I | |
| K221337 | Materialise TKA Guide System | Materialise N.V. | JWH | Class II | |
| K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA | Class II | |
| K220827 | Electric Wheelchair | Foshan Dahao Medical Technology Co.,Ltd. | ITI | Class II | |
| K220743 | CediTEC | Voco GmbH | EBI | Class II | |
| K213360 | SleepCheckRx | Resapp Health | MNR | Class II | |
| K221909 | J-Temp | Ultradent Products Inc. | EBF | Class II | |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | EZL | Class II | |
| K221395 | Footmotion Plating System | Newclip Technics | HRS | Class II | |
| K221176 | Insulin Pen Needle | Tianjin Huahong Technology Co., Ltd. | FMI | Class II | |
| K221036 | Astroglide Warming | Biofilm, Inc. | NUC | Class II | |
| K221026 | Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II |