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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K170114 | MagVita TMS Therapy - w/MagPro R20 | Tonica Elektronik a/S | OBP | Class II | |
| K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation, Inc | OLO | Class II | |
| K163707 | NuVasive CoRoent Ti-C System | Nu Vasive, Incorporated | MAX | Class II | |
| K163119 | NaviSuite SSI Edition | Medcom GmbH | LLZ | Class II | |
| K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | HWC | Class II | |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider | Surgical Instrument Services and Savings, Inc. | NUJ | Class II | |
| K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | LLZ | Class II | |
| K162620 | Remel Spectra ESBL | Remel Inc | JSO | Class II | |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | MEH | Class II | |
| K162266 | The Cranial Fusion System | Life Spine | NKG | Class II | |
| K170145 | Digital TENS Unit | Shenzhen Eapply Technology Co., Ltd. | NUH | Class II | |
| K171045 | Exactech® Truliant™ Line Extensions | Exactech, Inc. | JWH | Class II | |
| K170952 | syngo.CT View&GO | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | PSQ | Class II | |
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | OXE | Class II | |
| K170926 | BrainPulse 1100 | Jan Medical, Inc. | POP | Class II | |
| K170882 | Abl90 Flex, Abl90 Flex Plus | Radiometer Medical ApS | MQM | Class I | |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | DRE | Class II | |
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | Smith & Nephew, Inc. | OLO | Class II | |
| K170273 | Z-Dose29 | Zetta Medical Technologies, LLC | JAK | Class II | |
| K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | STERIS Corporation | FRC | Class II | |
| K163667 | RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) | Health Beacons, Inc. | PBY | Class II | |
| K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | FOZ | Class II | |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | OWP | Class II | |
| K162679 | IOB Temperature Management System | Iob Medical, Inc. | DWJ | Class II | |
| K162460 | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts | Wavi Co. | GXY | Class II | |
| K162319 | BabyDance Fertility Lubricant | Fairhaven Health | PEB | Class II | |
| K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | FRG | Class II | |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Limited | JGJ | Class I | |
| K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | OMP | Class II | |
| K162120 | Scope-Assist Flushing Sink | Wassenburg Medical B.V. | FEB | Class II | |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties, LLC | DZL | Class II | |
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) | Radiomed Corporation | IYE | Class II | |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | Boston Scientific Corporation | DQO | Class II | |
| K170949 | RadiForce MX315W | Eizo Corporation | PGY | Class II | |
| K170930 | Rsm 2430C | DRTECH Corporation | MUE | Class II | |
| K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | NEU | Class II | |
| K170220 | OneQ-SL s-Clean Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K170211 | Insight Dental System | Insight Dental System | DZE | Class II | |
| K162385 | Rapidec Carba Np | bioMerieux, Inc. | PTJ | Class II | |
| K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | GEX | Class II | |
| K162142 | Accessory Irrigation Adapter | Wilson-Cook Medical Inc. | ODC | Class II | |
| K161450 | Hamilton-C3 | Hamilton Medical AG | CBK | Class II | |
| K160730 | Instrument kits | Anthogyr | KCT | Class II | |
| K170964 | Zenius Spinal System | Medyssey USA | NKB | Class II | |
| K170942 | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | NKB | Class II | |
| K170938 | CalSet IGF-1 | Roche Diagnostics GmbH | JIT | Class II | |
| K170889 | HV Screw System | Wrightmedicaltechnologyinc | HWC | Class II | |
| K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | OVD | Class II | |
| K170572 | Summit Spine Yellowstone Lumbar Interbody Fusion System | Summit Spine | MAX | Class II |