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 |
|---|---|---|---|---|---|
| K083581 | Lanx Spinal Fixation System | Lanx, Inc. | MNH | Class II | |
| K083116 | Versafit Cup Double Mobility System | Medacta International SA | MEH | Class II | |
| K082679 | Laki Hand Fixation System, Model Tfx.3x.06.x | Sintea Biotech, Inc. | JEC | Class II | |
| K082634 | Vertigone Bppv Goggle | Vertigone, Inc. | LXV | Unclassified | |
| K082130 | Euroimmun Anti-Pr3-Hn-Hr Elisa (Igg) | Euroimmun US Inc. | MOB | Class II | |
| K080243 | Portable Oxygen Unit Sca900 | San Cheong Co., Ltd. | CAN | Class I | |
| K090318 | Carestream Drx-1 System | Eastman Kodak Company | MQB | Class II | |
| K082806 | Spinning Spiros, Model Ch-2000 | Abbott Medical | FPA | Class II | |
| K090878 | Modification to Terumo's Tenderflow Pediatric Venous Return Cannulae (X-Coating) | Terumo Cardiovascular Systems Corporation | DWF | Class II | |
| K090808 | Pinnacle3 Smartarc | Philips North America LLC | MUJ | Class II | |
| K090805 | V10, Three Wheel Scooter, Model Sc610v, V10, Three Wheel Scooter, Model Sc610vps, V10, Four Wheel Scooter, Model Sc710 | Pride Mobility Products Corp | INI | Class II | |
| K090743 | Yield Mini Doppler System | Broncus Technologies, Inc. | IYN | Class II | |
| K090669 | Rigidfix Biocryl Cross Pin Kits | DePuy Mitek, Inc. | MAI | Class II | |
| K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | OHP | Class II | |
| K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | Medtronic, Inc. | BTR | Class II | |
| K090327 | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling Claim of 50 Ug per Dm2 of Glove | Wear Safe (Malaysia) Sdn Bhd | LYY | Class I | |
| K090292 | Premise Modified | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K090249 | Modification to: Micro-Induction 1000 System | Harbinger Medical, Inc. | DPS | Class II | |
| K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter | William Cook Europe ApS | DTK | Class II | |
| K083782 | Regenerex Patella Components | Biomet Manufacturing Corp | MBH | Class II | |
| K083779 | Mak Oss Knee Femoral Components | Biomet Manufacturing Corp | KRO | Class II | |
| K083539 | Infant Cardiac Array | Advanced Imaging Research, Inc. | MOS | Class II | |
| K083466 | Md2000a Vital Sign Monitor, Model Md2000a | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K082846 | Apk Spo2 Pulse Oximeter Sensor | Apk Technology Co., Ltd | DQA | Class II | |
| K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra | Inter-Med, Inc. | KJJ | Unclassified | |
| K082327 | Invos Cerebral/somatic Oximeter System, Model: 5100C | Somanetics Corp. | MUD | Class II | |
| K081166 | Lightstream Low Level Laser | Solica Corporation | NHN | Class II | |
| K090713 | Elevate Prolapse Repair System with Pc Coated Intepro Lite- Apical and Posterior Prolapse Repair System, Anterior and Ap | American Medical Systems, Inc. | OTP | Class III | |
| K090624 | Cook Mreye Embolization Coils | Cook Inc. | KRD | Class II | |
| K090585 | Neosalus Cream | Quinnova Pharmaceuticals | FRO | Unclassified | |
| K090130 | Atmos S041 Wound | Atmos, Inc. | OMP | Class II | |
| K090003 | Zetajet | Bioject, Inc. | KZE | Class II | |
| K083693 | Pb 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | CBK | Class II | |
| K083622 | Lncs Oximetry Sensors | Masimo Corporation | DQA | Class II | |
| K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion Set | Cook Vandergrift, Inc. | FPA | Class II | |
| K083386 | Advia Chemistry Calcium_2 (Ca_2) Method, Models P/m 02189699 (40 Ml Fill), P/n 02189915 (70 Ml Fill) | Siemens Healthcare Diagnostics Inc. | CJY | Class II | |
| K082793 | Intergro Dbm | Highridge Medical, LLC | MQV | Class II | |
| K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | OMR | Class II | |
| K082333 | Asap Wound Dressing Gel | American Biotech Labs | FRO | Unclassified | |
| K081770 | Black Widow Anterior Buttress Plate | Omni Surgical, L.P. | KWQ | Class II | |
| K080950 | Stiwell Med4 | Otto Bock Austria | IPF | Class II | |
| K090759 | Biodrain Streamway Fluid Management System | Biodrain Medical, Inc. | JCX | Class II | |
| K090376 | Spinesmith Cynch Spinal System | Spine Smith Partners L.P. | MAX | Class II | |
| K090323 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | NLH | Class II | |
| K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 | Abbott Medical | DRB | Class II | |
| K090047 | Synthes (USA) 1.5Mm Mini Fragment Lcp System | Synthes (USA) Products LLC | HRS | Class II | |
| K083820 | Vasomedical Biox Cb-1305-C, 3 Channel ECG Holter Monitor, Model Cb-1305-C | Vasomedical, Inc. | DSH | Class II | |
| K083674 | Pk-141 Patient Cable | BIOTRONIK AG | DTC | Class II | |
| K083569 | Surgybone | Silfradent SRL | DZI | Class II | |
| K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | JAK | Class II |