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 |
|---|---|---|---|---|---|
| K061376 | El-Anca: Anti-Mpo, Anti-Pr3, Anti-Mpo and Anti-Pr3 | Theratest Laboratories, Inc. | MOB | Class II | |
| K061202 | Revere Stabilization System | Globus Medical, Inc. | NKB | Class II | |
| K061200 | Prestige CPAP Flow Generator with Prestige Humidifier | ResMed Corp | BZD | Class II | |
| K061056 | Randox Liquid Protein Calibrator | Randox Laboratories, Limited | JIX | Class II | |
| K053417 | M-Cor Hip Replacement System | Portland Orthopaedics Pty., Ltd. | LPH | Class II | |
| K053060 | Tcs Unbreakable | Thermoplastic Comfort Systems, Inc. | EBI | Class II | |
| K061909 | Highland Beam Delivery System, Model 3-099-002-00-00 | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K061767 | Quikclot 1St Response & Quikclot Acs+ | Z-Medica, LLC | QSY | Unclassified | |
| K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | KGN | Unclassified | |
| K061704 | Optilene Mesh | Aesculap Inc | FTL | Class II | |
| K061389 | Allthread Lactosorb Suture Anchor | Arthrotek, Inc. | JDR | Class II | |
| K061294 | Kfx Knotless Fixation System | Kfx Medical | MBI | Class II | |
| K061275 | Medline Syringes, Multiple | MEDLINE INDUSTRIES, LP - Northfield | FMF | Class II | |
| K061146 | Sbi Ulnar Head Implant | Small Bone Innovations, Inc. | KXE | Class II | |
| K060233 | Trokamed Gmbh Endoscopes and Accessories | Trokamed GmbH | GCJ | Class II | |
| K061939 | Modification to Allomatrix Custom | Wrightmedicaltechnologyinc | MQV | Class II | |
| K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - Kc330) | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (Ca0 Flex, Lactic Acid (La) Flex Reagent Cartri | Siemens Healthcare Diagnostics Inc. | DIC | Class II | |
| K061778 | Nuvasive Spherx II System | NuVasive Inc | MNH | Class II | |
| K061765 | Kalix II Implant | New Deal, S.A. | HWC | Class II | |
| K061607 | Storm Operating Kit, Model 1-10-0 | Intelligent Orthopaedics, Ltd. | HTY | Class II | |
| K061536 | Microscan Dried Gram Negative Mic/combo Panels | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | GEH | Class II | |
| K061307 | Bovie Inaflash Suture Remover Handle,charger,handle and Charger,kit,battery Pack | Apyx Medical Corporation | GEI | Class II | |
| K061304 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NQP | Class II | |
| K061168 | Pca 36Mm Femoral Heads | Howmedica Osteonics Corp | LPH | Class II | |
| K061124 | Orthopedic Source Press-Fit Hip | Orthopedic Source, Inc. | LPH | Class II | |
| K060897 | Embedding Tool, Model Te-1000 | Medigroup | FJS | Class II | |
| K060859 | Compound W Freeze Off Wart Removal System | OraSure Technologies, Inc. | GEH | Class II | |
| K060751 | Inovo, Inc. Accupulse Single Lumen Conserving Regulator | Inovo, Inc. | NFB | Class II | |
| K060186 | Polyplex Stimulating Catheter System | Te ME NA SAS | CAZ | Class II | |
| K053547 | Smartpill Gi Monitoring System | The Smartpill Corporation | NYV | Class II | |
| K053479 | Verify Dry Heat Label | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K053236 | David Pregnancy Test (Midstream) | Runbio Biotech Co.,Ltd | LCX | Class II | |
| K052407 | Architect Anti-Tpo Immunoassay, Calibrators & Controls | Fisher Diagnostics | JZO | Class II | |
| K061833 | Depuy Aml Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K061748 | Fragment Plate System | Hand Innovations, Inc. | KTT | Class II | |
| K061553 | Non-Sterile, Powder-Free Black Nitrile Examination Gloves | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K061243 | Smith & Nephew Modular Femoral Head | Smith & Nephew, Inc. | KWL | Class II | |
| K061090 | Galileo Gold Asv | Hamilton Medical AG | CBK | Class II | |
| K060891 | Virtual | Ivoclar Vivadent, Inc. | ELW | Class II | |
| K060675 | Envitec Reusable Softip Y Spo2 Sensors | Envitec-Wismar GmbH | DQA | Class II | |
| K053624 | Medicon Stern-a-Fix Sternal Closure System | Medicon, E.G. | HRS | Class II | |
| K053215 | Surgical Mesh System | NuVasive Inc | FTL | Class II | |
| K052574 | Compact Plus - Extreme - Perfect Plus | J.O. Suarez & Cia, Ltda | EIA | Class I | |
| K061710 | Cps Direct Pl Peelable Outer Guide Catheter; Accessory, Valve Bypass Tools | Abbott Medical | DQY | Class II | |
| K061641 | Echo View/shimasonic Diagnostic Ultrasound System, Model Sarano | Shimadzu Medical Systems | IYO | Class II | |
| K061535 | Gc Xlc-100 Capsule | GC America Inc. | EMA | Class II | |
| K061349 | Opus Labralock P Knotless Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K061066 | Synergy Hip System | Smith & Nephew, Inc. | LZO | Class II |