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 |
|---|---|---|---|---|---|
| K082967 | Mortara Stress Echo Bed | Medical Positioning Inc | DPS | Class II | |
| K082662 | V-Loc 180 Absorbable Wound Closure Device | Surgical Devices, Tyco Healthcare Group LP | GAM | Class II | |
| K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | LLH | Class I | |
| K082227 | Minicap Hemoglobin(e) Kit, Model 2207, 2227 | Sebia, Inc. | GKA | Class II | |
| K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | MNI | Class II | |
| K081433 | Ek/p. Aeruginosa Pna Fish | Advandx, Inc. | JSS | Class I | |
| K090473 | Discovery Elbow - X-Small | Biomet Manufacturing Corp | JDC | Class II | |
| K090439 | Forum | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K090433 | I_open 0.4T | Beijing Wandong Medical Equipment Co., Ltd. | LNH | Class II | |
| K083792 | Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055 | Medshape, Inc. | HWC | Class II | |
| K083562 | Stryker Spine Nulock Anterior Cervical Plating System | Stryker Corp. | KWQ | Class II | |
| K083234 | Kimberly-Clark Kc100 Surgical Drapes, Model Kc 100, Kimberly-Clark Kc100 Surgical Equipment Covers, Model Kc 100 | Kimberly-Clark Corporation | KKX | Class II | |
| K082558 | Comfortlite Nasal Mask | Respironics, Inc. | BZD | Class II | |
| K082465 | Everon | Earlysense, Ltd. | BZQ | Class II | |
| K081946 | Supra Twin Ophthalmic Laser Photocoagulator | Quantel Medical | HQF | Class II | |
| K081775 | The Medcomp .010 Vascular Guidewires | Medcomp | DQX | Class II | |
| K090625 | Wireless Portable Detector Fd-W17 | Philips North America LLC | MQB | Class II | |
| K090623 | Digital Radiography Cxdi-40G Compact | Canon Medical Components U.S.A., Inc. | MQB | Class II | |
| K090310 | Equivabone | Etex Corp. | MQV | Class II | |
| K090120 | Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus Cable, Model M-4700-106 | Biosense Webster Inc | DRF | Class II | |
| K090067 | Bactrack Select Breathalyzer, Model S80 | KHN Solutions LLC | DJZ | Class I | |
| K083853 | Immulite 2000 3Gallergy Specific Ige Assay Kit | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K083606 | Sensititre 18-24 Hour Suseceptibility Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/t Protein Control Lc | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K083224 | Cpi Rad Vision, Model Vzw2944xx-Yy | Communications & Power Industries Canada, Inc. | MQB | Class II | |
| K062187 | Betachek Glucose Test | National Diagnostic Products | NBW | Class II | |
| K090664 | Devon Accubp Cuff | Devon Medical, Inc. | DXQ | Class II | |
| K090634 | Phaseal Protector P14, P21, P28 and P50 | Carmel Pharma AB. | LHI | Class II | |
| K090466 | Digital Retinal Camera, Cr-1 Mark II | Canon, Inc. | HKI | Class II | |
| K090286 | Pressuremate Manual Femoral Access Compression Device | Advanced Vascular Dynamics | DXC | Class II | |
| K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090 | Unicare Biomedical, Inc. | LYC | Class II | |
| K090080 | Cirrus Open | Mri-Tech Sp. Zo.O. | LNH | Class II | |
| K083891 | Validate Thyroid Calibration Verification Test Set, Model 901 | Maine Standards Co. | JJY | Class I | |
| K083886 | Simpler Mini Implant, Models Sm 5002, Sm 5003, Sm 5004 | Simpler One Stop | DZE | Class II | |
| K083852 | Biograph 16 True Point Systems | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K083789 | Ace Fischer External Fixation System | Depuy Orthopaedics Inc. | KTT | Class II | |
| K083780 | Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model Spl03.39/40/41/42 (Details in 510(K) Annex 2 | Audio Technologies S.r.l. | ETA | Class II | |
| K083750 | Capnostat / Capnoflex CO2 System | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K082853 | Clinical Oxygen Dose Recorder (Codr), Model 300-Cr | Inspired Technologies, Inc. | MNR | Class II | |
| K082439 | Disposable Angiographic Syringe, Model(s) CT-200-Ne, CT-200-Ma, CT-200+200-Ma, CT-200-Lf, CT -100-Ne, CT-200Ne, CT-50+Ct | Shandong Weigao Medical Polymer Co., Ltd. | DXT | Class II | |
| K081346 | Hoya Is Injector System | Hoya Surgical Optics, Inc. | MSS | Class I | |
| K081168 | Brit Pacs Systems | Brit Systems | LLZ | Class II | |
| K090521 | Diamondback 360 Dbx | Cardiovascular Systems Incorporated | MCW | Class II | |
| K090509 | Foxcross .035 Pta Catheter 14 Mm X 20Mm X 80 Cm, Model 10342-20, Foxcross .035 Pta Catheter | Abbott Vascular-Vascular Solutions | DQY | Class II | |
| K090483 | Sursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient Monitors | Philips North America LLC | DPS | Class II | |
| K090454 | Allure Mb Ceramic Brackets | Dentsply Interntional | NJM | Class II | |
| K090408 | Modification to: Dss Stabilization System | Paradigm Spine GmbH | NKB | Class II | |
| K090136 | Steris Cmax Xlt Surgical Table | STERIS Corporation | FQO | Class I | |
| K083843 | Locking Anatomic & Composite Plating System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K083830 | Oscar Bone Resector | Orthosonics, Ltd. | JDX | Class II |