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 |
|---|---|---|---|---|---|
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen BSX Technology Electronics Co.,Ltd | DXN | Class II | |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | ODP | Class II | |
| K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | Basic Medical Technology Inc. | LZA | Class I | |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Corp. | QJP | Class II | |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto U.S.A., Inc. | HIS | Class II | |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical Ltd | OMP | Class II | |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics Inc. | JWH | Class II | |
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | POM | Class II | |
| K250248 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K243696 | Aview Cac | Coreline Soft Co., Ltd. | QIH | Class II | |
| K243503 | VIA360™ Surgical System | New World Medical, Inc. | MRH | Class II | |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | POK | Class II | |
| K243212 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | FLL | Class II | |
| K243081 | Green X 21 (PHT-90CHO) | Vatech Co., Ltd. | OAS | Class II | |
| K242776 | LimFlow V-Ceiver | LimFlow Inc. | MMX | Class II | |
| K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K242198 | ICS Dizcovery (1091) | Natus Medical Denmark ApS | GWN | Class II | |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 | MWI | Class II | |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | WONTECH Co., Ltd. | GEX | Class II | |
| K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | QOF | Class II | |
| K241527 | Pastelle Pro | WONTECH Co., Ltd. | GEX | Class II | |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech LLC | LCX | Class II | |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | |
| K243778 | Body Temperature Software (BTS) | Fitbit LLC | QZA | Class II | |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona Inc | KIF | Class II | |
| K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | QQX | Class II | |
| K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | OBP | Class II | |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd | ELC | Class II | |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra Inc. | NRY | Class II | |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | Boston Aesthetics Inc | GEI | Class II | |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics Inc. | MBH | Class II | |
| K241410 | EDEN ControlCath | Jmt Co., Ltd. | BSO | Class II | |
| K243962 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | |
| K243961 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | |
| K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer GmbH | HSB | Class II | |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. | MYF | Class II | |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K243250 | SubtleHD (1.x) | Subtle Medical Inc | QIH | Class II | |
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | KLA | Class II | |
| K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics | LNH | Class II | |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry Inc. | PPW | Class II | |
| K241425 | AspenView | Aspen Imaging Healthcare, Inc | LLZ | Class II | |
| K241418 | OptoMonitor 3 | Opsens Inc. | DXO | Class II | |
| K250200 | InbellaBody System | Inbella Medical Inc. | GEI | Class II | |
| K243628 | Vivid T9/Vivid T8 | GE Healthcare | IYN | Class II | |
| K243620 | Vivid iq | GE Healthcare | IYN | Class II | |
| K243518 | BinaxNOW™ COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | QYT | Class II | |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta Ltd. | KCT | Class II |