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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K073293 | Durette Implant | Oculo Plastik, Inc. | HPZ | Class II | |
| K073176 | Kanteron Dicom Station (Kds), Model 3.0 | Monica Veytia | LLZ | Class II | |
| K073095 | Tumark Professional, Model 271560; Mr- Tumark Professional, Model 601560 | SOMATEX Medical Technologies GmbH | NEU | Class II | |
| K072891 | Sinus Spacer | Acclarent Inc | KAM | Class I | |
| K072702 | Stryker Antimic Catheter | Stryker Corp. | BSO | Class II | |
| K072527 | Autopulse Resuscitation System, Model 100 | ZOLL Circulation, Inc. | DRM | Class II | |
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 | Biokit, S.A. | LEH | Class II | |
| K071525 | Activated Aspartate Aminotransferase | Abbott Medical | CIT | Class II | |
| K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | HRX | Class II | |
| K080391 | Drive Solstice Oxygen Concentrator | Medical Depot Inc. | CAW | Class II | |
| K073361 | Muscle Pain Device (Mpd) | Stevens Proof of Concept, Inc. | IPF | Class II | |
| K072957 | Evis Exera II 180 System | Olympus Medical Systems Corp. | NWB | Class II | |
| K072301 | 5Mm Protege Everflex Self Expanding Biliary Stent System, Model Prp35-05 | Medtronic, Inc. | FGE | Class II | |
| K073450 | Sutter Electrosurgical Cables | Sutter Medizintechnik GmbH | GEI | Class II | |
| K073274 | Spinal Sphere System | Life Spine | NVR | Class III | |
| K072686 | Axsym Hba1c Reagents, Axsym Hba1c Calibrators, Axsym Hba1c Controls | Axis-Shield Diagnostics, Ltd. | LCP | Class II | |
| K080280 | Sub-Talar Lok, Model 7-11 Mm | Instratek, Inc. | HWC | Class II | |
| K080211 | Model Tsx-101A/h/i Aquilion 32/64 Sp CT System | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K080130 | Occlufast Cad | Zhermack S.p.A. | ELW | Class II | |
| K080076 | Rx Dc X-Ray Unit | Cefla S.C.R.L. | EHD | Class II | |
| K080010 | Nocc Hydrophilic Wound Dressing | Kytogenics, Inc. | KGN | Unclassified | |
| K073401 | Earpopper, Model Ep-2000, Ep-2100, Ep-3000 | Micromedics, Inc. | MJV | Unclassified | |
| K073265 | Apieron Insight Exhaled Nitric Oxide (Eno) System | Apieron, Inc. | MXA | Class II | |
| K073034 | Amt Initial Placement Gi Kit (E2418) and Amt Dilator Set (E2419) | Applied Medical Technology Inc | KNT | Class II | |
| K072307 | Quantitative Neuroq 3.0 | Syntermed, Inc. | KPS | Class II | |
| K063175 | Ipup 200 (Intelligent Pressure Ulcer Prevention) | Medical Technology Systems, Inc. | MOC | Class II | |
| K080540 | Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K080500 | Modification to: Acumen Single-Lumen Delivery Sheath, Models Bls-10, Bls-9, Bls-7 | Acumen Medical, Inc. | DYB | Class II | |
| K080461 | Star St and Arrhythmia Software, Release J.0 | Philips North America LLC | MLD | Class II | |
| K080407 | Blackstone Sfs Parallel Rod Connectors | Blackstone Medical, Inc. | MNI | Class II | |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | Blackstone Medical, Inc. | KWP | Class II | |
| K080393 | Modification to Rebound Hrd | Minnesota Medical Development, Inc. | FTL | Class II | |
| K080133 | Mountable Endoscopic Blade | A.M. Surgical, Inc. | EMF | Class I | |
| K073636 | Tinnitus Sound Generator Module | GN Resound A/S | KLW | Class II | |
| K073623 | Atlantis 018 Peripheral Imaging Catheter | Boston Scientific Corporation | ITX | Class II | |
| K073604 | Dimension Exl with Lm Clinical Chemistry System, Dimension Ft4l Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K073591 | Microstaar Msi Injector Foam Tip System | Staar Surgical AG | MSS | Class I | |
| K073586 | Microstaar Indigo Injector Foam Tip System | Staar Surgical AG | MSS | Class I | |
| K073567 | Biolox Option Ceramic Femoral Head System, Model 8777 Series | Zimmer GmbH | LZO | Class II | |
| K073558 | Sensititre 18-24 Susceptibility Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K073343 | Ace Surgical Secure-Mini Implant System, Model 09-270X-Xx | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | Medtronic, Inc. | KRH | Class II | |
| K073287 | Prevadh Mesh | Sofradim Production | FTL | Class II | |
| K073260 | Liisa Lever Integrated Interventional System Adapter, Model Vsl-109 | Device Partners International | DTL | Class II | |
| K072864 | St. Jude Medical, Cps Duo Left Heart Lead Delivery System | St. Jude Medical, Cardiac Rhythm Management Divisi | DRB | Class II | |
| K071120 | Aemed Stimpad Acu-TENS Transcutaneous Electrical Nerve Stimulator, Model 021999 | Aemed, Inc. | GZJ | Class II | |
| K063787 | Inplex Cf Molecular Test | Third Wave Technologies, Inc. | NUA | Class II | |
| K080352 | Micro Qa+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix Aq+ Anchor with #3-0 Orthocord Suture | DePuy Mitek, Inc. | HWC | Class II | |
| K080207 | Danyang Huayi K2 and K7 Wheelchairs | Danyang Huayi Medical Supply & Equipment Co, Ltd | IOR | Class I | |
| K073538 | Dual Chamber Tpn Container | B.Braun Medical, Inc. | KPE | Class II |