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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | Cefla S.C. | OAS | Class II | |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. | GWM | Class II | |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | SRI Trang Gloves (Thailand) Public Company Limited. | LZA | Class I | |
| K200517 | Standard Trocar | Standard Bariatrics | GCJ | Class II | |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Medical | CHL | Class II | |
| K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | Orthofix SRL | ODP | Class II | |
| K200001 | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K193640 | ClearCalc | Radformation, Inc. | MUJ | Class II | |
| K193329 | PreXion3D Explorer EX | Prexion Corporation | OAS | Class II | |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | DSI | Class II | |
| K192138 | Rejuvapen NXT | Refine USA, LLC | QAI | Class II | |
| K191935 | Nautilus Smart ECMO Module | Mc3 Incorporated | BYS | Class II | |
| K191867 | ATLAS Plating System | Mirus, LLC | HRS | Class II | |
| K191574 | OxSAT 100 | S.L.P., Ltd. | DQA | Class II | |
| K200632 | TCAT TKA Instrument Tray Set | Think Surgical Inc. | KCT | Class II | |
| K200598 | Voyant Maryland Fusion Device | Applied Medical Resources Corp | GEI | Class II | |
| K200477 | Flex Body Speeder | Quality Electrodynamics | MOS | Class II | |
| K200411 | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | LHN | Class II | |
| K200144 | HI-TORQUE Steelcore Bare Guide Wire | Abbott Vascular | DQX | Class II | |
| K193571 | Go2Wire Guide Wire | Merit Medical System, Inc. | DQX | Class II | |
| K193300 | AIMI-Triage CXR PTX | Radlogics, Inc. | QFM | Class II | |
| K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | Medtronic, Inc. | FTL | Class II | |
| K192108 | Panthera Dental Milled Bars | Panthera Dental Inc | NHA | Class II | |
| K191885 | Standard Bougie | Standard Bariatrics | KNT | Class II | |
| K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined BD) | FOZ | Class II | |
| K193654 | BlueStar Rx | Welldoc | MRZ | Class II | |
| K193218 | Innovision Audio | Innovere Medical, Inc. | LNH | Class II | |
| K192013 | VERTICALE® Cervical System | Silony Medical GmbH | NKG | Class II | |
| K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | MBH | Class II | |
| K200776 | Eko CORE | Eko Devices, Inc. | DQD | Class II | |
| K200576 | ClearMask Transparent Surgical Face Mask | Clearmask, LLC | FXX | Class II | |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | HTN | Class II | |
| K200312 | Tryptik Ti | Spineart SA | ODP | Class II | |
| K200308 | MTS Lefamulin 0.016- 256 µg/mL | Liofilchem S. R. 1. | JWY | Class II | |
| K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | GGZ | Class II | |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics Inc. | LTK | Class II | |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics, LLC | LSR | Class II | |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics, LLC | LSR | Class II | |
| K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K193494 | Origin™ Anterior Cervical Plate System | Orthopaedic & Spine Development | KWQ | Class II | |
| K193250 | Irrigation Tubing with CO2 or Air | KEYMED (Medical & Industrial Equipment) Ltd | OCX | Class II | |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | MEDLINE INDUSTRIES, LP - Northfield | KGO | Class I | |
| K192558 | Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter | Mivi Neurovascular | DQY | Class II | |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | HONSUN (NANTONG) Co., Ltd. | DXQ | Class II | |
| K192401 | Straumann Screw-Retained Abutments | Straumann USA, LLC | NHA | Class II | |
| K191970 | Diode Laser Hair Removal System | Beijing Sano Laser S&T Development Co, Ltd. | GEX | Class II |