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 |
|---|---|---|---|---|---|
| K011174 | Paradigm-Fontona Perovskite Nd: Yap Laser System and Accessories | Fotona D.D. | GEX | Class II | |
| K011070 | Drt4 Laser Doppler Perfusion and Temperature Monitor | Moor Instruments Ltd. | GEX | Class II | |
| K010989 | Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal, Model 8119, 8120, 8130, 8131 | Interpore Cross Intl. | MQP | Class II | |
| K013496 | Modification to Skylight Imaging System | Philips North America LLC | KPS | Class II | |
| K013316 | Sickle-Chex | Streck Laboratories, Inc. | GHM | Class II | |
| K012617 | Jostra Arterial Perfusion Cannulae, Model a... | Jostra AG | DWF | Class II | |
| K012429 | Sureset Infusion Set, Model 8023 | Applied Diabetes Research, Incorporated | FPA | Class II | |
| K011899 | Pf 5050 Pressure Unit, Model Pf 5050 | Perimed AB | DPW | Class II | |
| K011861 | Bernoulli Ventilator Management System | Cardiopulmonary Corp. | MOD | Class II | |
| K011195 | Prizm Blade (Moria Model) Lsk / Mk8510lsk; Prizm Blade (Moria Model) Cb / Mk8511cb | Surgin Surgical Instrumentation, Inc. | HNO | Class I | |
| K010868 | Psychemedics Ria Cocaine Assay | Psychemedics Corp. | KLN | Class II | |
| K010739 | Watch-Pat 100 | Itamar Medical (C.M.) 1997, Ltd. | MNR | Class II | |
| K012942 | The V Bag, Catalog Number Vb1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog Number Vacbox1500 | Circulatory Technology, Inc. | DTN | Class II | |
| K012794 | Prime-Dent Chemical Cure Pit & Fissure Sealant | Prime Dental Manufacturing, Inc. | EBF | Class II | |
| K012552 | Sciton Image Hair Removal Laser | Sciton, Inc. | GEX | Class II | |
| K012545 | Aramis Dermatlogic Laser | Lumedics, Ltd. | GEX | Class II | |
| K012396 | Ontrak Testcard 9 | Roche Diagnostics GmbH | DKZ | Class II | |
| K011799 | Eversticknet | Stick Tech Ltd. | EBI | Class II | |
| K011788 | Everstick | Stick Tech Ltd. | EBI | Class II | |
| K002937 | Tst Control Integrator for Steam Sterilizers | Sybron Dental Specialties, Inc. | LRT | Class II | |
| K013481 | Dual Energy and Tissue Equalization Software Option | GE Healthcare | KPR | Class II | |
| K013373 | Omni C Analyzer | Roche Diagnostics GmbH | CEM | Class II | |
| K013326 | Modification to: Datascope 8Fr. Polyimide Alt B Iab, 25Cc, 34Cc, 40Cc, Datascope Insertion Kit for 8 Fr, Polyimide Alt B | Datascope Corp. | DSP | Class II | |
| K013306 | Minime Nasal Mask, Model P/n 50220 | SleepNet Corporation | BZD | Class II | |
| K012977 | Varices Injection Needle | Endo-Therapeutics, Inc. | FBK | Class II | |
| K012921 | Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K012843 | Portadur P 2, Model #2031 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012829 | Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis | Biocare Corp. | KQO | Class I | |
| K012779 | Iconnection 3D | Hinnovation, Inc. | LLZ | Class II | |
| K012626 | Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor | Osi Medical, Inc. | DQA | Class II | |
| K012591 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | HRY | Class II | |
| K012563 | Deep Gray | Cortechs Labs, Inc. | LLZ | Class II | |
| K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc | KPR | Class II | |
| K012536 | Reprocessed Powered Arthroscopic Accessories | Sterilmed Inc | HRX | Class II | |
| K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx | GE Healthcare | MSX | Class II | |
| K012492 | Kadance 2000 | Kada Research, Inc. | LBB | Class II | |
| K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump Use | Zevex, Inc. | KNT | Class II | |
| K011985 | Smith & Nephew Phoenix 5.0 Allograft Anchor Kit | Smith & Nephew, Inc. | MAI | Class II | |
| K011933 | Glycosal II Hba 1C Test | Provalis Diagnostics, Ltd. | LCP | Class II | |
| K011439 | Modification to Bioz.com Hemodynamic Monitor | Cardiodynamics International Corp. | DSB | Class II | |
| K012835 | Porta Maximum, Model# 2066 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012834 | Porta Geo Ti Model #2004 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012831 | Bio Portadur, Order-No.:2017 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012828 | Porta Smk 82, Model 2032 | Wieland Edelmetalle GmbH & Co. | EJS | Class II | |
| K012827 | Porta Aurium, Model 2067 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012826 | Bioporta G, Model 2052 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression Material | S & C Polymer GmbH | ELW | Class II | |
| K012761 | Prime-Dent Visible Light Cure Pit & Fissure Sealant | Prime Dental Manufacturing, Inc. | EBC | Class II | |
| K012527 | Ksea Sialoendoscopes and Accessories | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K012517 | Cerec3 Vitablocks | Sirona Dental Systems GmbH | ELW | Class II |