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 |
|---|---|---|---|---|---|
| K071024 | Modification to: Rainbow Adhesive Co-Oximetry Sensors | Masimo Corporation | DQA | Class II | |
| K070921 | Bionexia Hcg Pregnancy Cassette and Dipstick Tests, Model 08-Hcg and 02-Hcg | Applied Dna Technologies, Inc. | JHI | Class II | |
| K070890 | Everlife Interferential Current Therapy, Model If-100507 | Everlife Medical Equipment Co., Ltd. | LIH | Class II | |
| K070770 | Gore Balloon Sheath | W. L. Gore & Associates, Inc. | MJN | Class II | |
| K070744 | Narrow Neck Temporary Coping | Straumann USA, LLC | NHA | Class II | |
| K070699 | Avante Z; Pellet, Pressable Stain, Add-on Porcelain, Porcelain | Pentron Ceramics, Inc. | EIH | Class II | |
| K070696 | Interacoustics Assr, Eclipse System (Cabinet Name) | Interacoustics a/S | GWJ | Class II | |
| K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | KLW | Class II | |
| K070613 | Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit | Boston Scientific Corporation | LJS | Class II | |
| K070559 | Polymap Pwr-08-03 | Polymap Wireless | NBW | Class II | |
| K070426 | Silhouette, Model 1000.01 | Aranz Medical Limited | FXN | Class I | |
| K070351 | Space 360 Delivery System | Dfine, Inc. | NDN | Class II | |
| K063681 | Tecno-Gaz Andromeda Vacuum Cs Autoclave | Mediline Italia S.r.l. | FLE | Class II | |
| K063526 | A-M Systems Viromax Viral and Bacterial Filter | A-M Systems | CAH | Class II | |
| K063339 | Medick Mhm200 Personal Heart Monitor | Medick Healthcare, Ltd. | MLO | Class II | |
| K061123 | Palm ECG Recorder, Model Ep-201/202 | Parama-Tech Company., Ltd. | DPS | Class II | |
| K071611 | Neocoil 3.0T 8-Channel Shoulder Array Coil | NeoCoil, LLC | MOS | Class II | |
| K071506 | Echelon Spectroscopy Package | FUJIFILM Healthcare Americas Corporation | LNI | Class II | |
| K071433 | Sms Glucose Control, Model 2120059 | Specialty Medical Supplies | JJY | Class I | |
| K071396 | Crc 25 Series (Crc 25R, Crc 25Pet, Crc 25W) Dose Calibrators | Mirion Technologies (Capintec), Inc. | KPT | Class II | |
| K070786 | X-Pod Adjustable Vertebral Body Replacement | Theken Companies LLC | MQP | Class II | |
| K063670 | Modifications to Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K062630 | Ossipro Bone Substitute Material | Etex Corp. | MQV | Class II | |
| K061496 | Sas Legionella Test, Sas Legionella Dipstick Test | SA Scientific, Ltd | MJH | Class II | |
| K061239 | Euroimmun Anti-Hsv-2 Elisa (Igg) and Anti-Hsv-1 Elisa (Igg) Kit | Euroimmun US Inc. | MYF | Class II | |
| K071570 | Ge Lunar Body Composition Software | GE Medical Systems Lunar | KGI | Class II | |
| K071436 | Regius Unitea | Konica Minolta Medical & Graphic, Inc. | LLZ | Class II | |
| K071103 | Habib Hexablate | Emcision, Ltd. | GEI | Class II | |
| K070619 | Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K063768 | Titanium Scalloped Abutment | Vident | NHA | Class II | |
| K062878 | Ezpacs, Version 3.0 | Advanced Imaging Solutions, LLC | LLZ | Class II | |
| K071607 | Asa01 Heavy Duty Suction Pump | Zhongshan A&j Medical Equipment Co., Ltd. | BTA | Class II | |
| K071523 | Full Auto Wrist Digital Blood Pressure Monitor, Models Bp1600, Bp1650, Bp1700 and Bp1750 | Genexel-Sein, Inc. | DXN | Class II | |
| K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | JAK | Class II | |
| K071319 | I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02 | Bio-Rad, Diagnostics Grp. | GGN | Class II | |
| K071268 | Microscan Synergies Plus Gram Positive Mic/combo Panels with Tetracycline | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K070849 | Depuy Gck Femoral and Tibial Components | Depuy Orthopaedics Inc. | NPJ | Class II | |
| K070791 | Pm Series Patient Monitors, Models Pm-9000 Express and Pm-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K070672 | Massage Mattress Vm9100rm | Metek GmbH | JFB | Class II | |
| K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15Fr X 24Cm, 15Fr X 28Cm, 15Fr X 32Cm | Ash Access Technology, Inc. | MSD | Class II | |
| K070819 | Variant II Turbo Link Hemoglobin A1c Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, | Bio-Rad Laboratories Inc., Clinical Systems Divisi | LCP | Class II | |
| K070055 | Bonalive Granules and Bonalive Plates | Vivoxid, Ltd. | LYC | Class II | |
| K063393 | Small Stature Spacers | Highridge Medical, LLC | MQP | Class II | |
| K063376 | Easystat Ph, Pco2, Po2, Htc, Na, K, Cl Analyzer | Medica Corp. | CHL | Class II | |
| K071401 | X3c 2200 Digital Radiographic System | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K071323 | Powdered Latex Examination Gloves | Quality Gallant Sdn. Bhd. | LYY | Class I | |
| K071297 | Impax Se Sigmacom Client (Pacs Workstation) | AGFA Healthcare Corp. | LLZ | Class II | |
| K071192 | Blugoo Hd | Lancer Orthodontics, Inc. | ELW | Class II | |
| K071184 | Synthes (USA) Variable Angle-Locking Compression Plate (Va-Lcp) Distal Radius System | Synthes (USA) Products LLC | HRS | Class II | |
| K071178 | Otomedics Soft Tympanostomy Tube | Otomedics Advanced Medical Technologies, Ltd. | ETD | Class II |