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 |
|---|---|---|---|---|---|
| K961790 | Point-of-Care Blood Gas Monitor System | Optical Sensors, Inc. | CCC | Class II | |
| K971058 | Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404) | Medical Analysis Systems, Inc. | DIF | Class I | |
| K970956 | Certain Complete Levels 1,2, and 3; Cvm Levels 1,2,3,4, and 5 | Chiron Diagnostics Corp. | JJY | Class I | |
| K970932 | Orgentec Micro-Albumin Eia Assay | American Laboratory Products Company | JIR | Class I | |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0) | Alko Diagnostic Corp. | JIX | Class II | |
| K970862 | Spinalscopics | Quantimetrix Corp. | JJY | Class I | |
| K970856 | Cardioisozyme, Ck/ld Isoenzyme Control | Medical Analysis Systems, Inc. | JJT | Class I | |
| K970656 | Hydroflex | GC America Inc. | ELW | Class II | |
| K970265 | One Step Urine Drug of Abuse Methamphetamine Test | Drial Consultants, Inc. | DKZ | Class II | |
| K970259 | E-Z Set Infusion Set/saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | FPA | Class II | |
| K970250 | Clinistrip | Teco Diagnostics | JIL | Class II | |
| K970239 | Is-Anti-Scl-70 Test System (720-280) | Diamedix Corp. | LLL | Class II | |
| K970238 | Is-Anti-Sm/rnp (720-270) | Diamedix Corp. | LLL | Class II | |
| K970237 | Is-Anti-Ssb Test System (720-260) | Diamedix Corp. | LLL | Class II | |
| K970228 | Is-Anti-Jo-1 Test System | Diamedix Corp. | LLL | Class II | |
| K970227 | Immulite 2000 Automated Immunoassay Analyzer | Siemens Healthcare Diagnostics Inc. | JJE | Class I | |
| K970220 | Is-Anti-Sm Test System | Diamedix Corp. | LLL | Class II | |
| K970218 | Is-Anti-Ssa Test System | Diamedix Corp. | LLL | Class II | |
| K970166 | Natural-Hip System Cocr Revision Stem | Intermedics Orthopedics | LZO | Class II | |
| K964887 | Vidas C. Difficile Toxin a II Assay | Biomerieux Vitek, Inc. | LLH | Class I | |
| K964787 | Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System | Mardx Diagnostics, Inc. | LLL | Class II | |
| K963948 | Minimed Insulin Pump, Model 505 | Medtronic, Inc. | LZG | Class II | |
| K963918 | Immulite Cocaine Metabolite | Siemens Healthcare Diagnostics Inc. | DIO | Class II | |
| K963755 | Spiracle Technology - Model 302 Ox Inhalator | Spiracle Technology | CBP | Class II | |
| K962208 | Nichols Advantage Chemiluminescence Cortisol Kit | Nichols Institute Diagnostics | CGR | Class II | |
| K970715 | System B Heat Source | Sybron Dental Specialties, Inc. | EAT | Class II | |
| K970451 | Downscan 120 | Merlin Engineering Works, Inc. | LLZ | Class II | |
| K970287 | Lumbar Puncture Kit | B.Braun Medical, Inc. | FMJ | Class II | |
| K970157 | Laserscope Automatic Eye Protection Filter | Laserscope | GEX | Class II | |
| K970088 | Riwo Drive with Footswitch/motor Handle, Coomplete,6000rpm/3000rpm/rotary Blades and Abraders See Section 1: | Richard Wolf Medical Instruments Corp. | HWE | Class I | |
| K963126 | Aesop System and Accessories | Computer Motion, Inc. | GCJ | Class II | |
| K971209 | Clinitek Hcg Test Strips | Bayer Corp. | JHI | Class II | |
| K970626 | Easy Cam | I.C.S. | EIA | Class I | |
| K970606 | Computed Tomography X-Ray System | GE Healthcare | JAK | Class II | |
| K970534 | Picture Archiving & Communications Device | Multimedia Solutions | LLZ | Class II | |
| K970342 | Cavitron Jet with Sps System | Dentsply Intl. | ELC | Class II | |
| K970156 | Imex Futuraldop Pro | Imex Medical Systems, Inc. | IYO | Class II | |
| K970154 | Kodak Ektasian Hg Film (Ehg-15) | Eastman Kodak Company | IWZ | Class I | |
| K965233 | Sharpsite Ac | Xomed, Inc. | EOB | Class II | |
| K965083 | Super-Dent Alginate,normal Set, Fast Set,super Deluxe Dustless Alginate, Normal Set, Deluxe Dutless Alginate, Fast Set | S.S. White Mfg., Ltd. | ELW | Class II | |
| K964360 | Vent(ventcheck) Handheld Respiratory/mechanics Monitor Model 101 | Novametrix Medical Systems, Inc. | BZC | Class II | |
| K964161 | Heartport Endoaortic Clamp | Heartport, Inc. | DXC | Class II | |
| K963076 | Laparoscopic Bone Anchored Urethropexy Instrument Tray | Louisville Laboratories, Inc. | HET | Class II | |
| K962638 | Tonocap, Tc-200 and Accessory Catheters | Instrumentarium Corp. | CCK | Class II | |
| K960928 | Syringefilter | Arbor Technologies, Inc. | BSN | Class II | |
| K945586 | Flexible Dilating Sheath | Med Institute, Inc. | DRE | Class II | |
| K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | JDW | Class II | |
| K970462 | Acromed Anterior Cervical Stabilization System | Acromed Corp. | KWQ | Class II | |
| K970399 | Kwik Kold Peri Cold Pack (Catalog Number Tbd) | Medtronic, Inc. | IMD | Class I | |
| K970108 | Harmonies Menstrual Tampon | Ecoprogress Intl. | HEB | Class II |