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 |
|---|---|---|---|---|---|
| K000587 | Shuttle Stop | Isotis NV | LZN | Class II | |
| K000368 | Eyecap Imaging System | Clement Clarke Intl., Ltd. | HKI | Class II | |
| K000332 | Noga Cardiac Navigation System | Biosense Webster Inc | DQK | Class II | |
| K993520 | H20nly Complete Water Purification System for Hemodialysis | Serv-A-Pure Co. | FIP | Class II | |
| K991422 | Powder-Free Nitrile Examination Glove (Tested for Use with Chemotherapy Drugs) | Shen Wei (USA), Inc. | LZA | Class I | |
| K001238 | Lorenz Titanium Fracture / Reconstruction Plating System | Biomet Microfixation | JEY | Class II | |
| K001153 | Modification to Steathstation Treatment Guidance Platform | Medtronic Surgical Navigation | HAW | Class II | |
| K001140 | Ids5 Image Display System | Sectra AB | LLZ | Class II | |
| K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4 | Boston Scientific Corporation | HCG | Class II | |
| K001057 | Agilent Information Center Software for M3150a and M3153a and Agilent M2/m3/m4 Compact Portable Patient Monitor | Agilent Technologies, Inc. | DSI | Class II | |
| K000968 | 3181 Duo Delivery System | A-dec, Inc. | EIA | Class I | |
| K000967 | 4635 Assistant's Instrumentation | A-dec, Inc. | EIA | Class I | |
| K000966 | 4631 Duo Delivery System | A-dec, Inc. | EIA | Class I | |
| K000896 | Powderfree Latex Surgeon's Gloves with Protien Labeling Claim (50 Mocrograms or Less | Fitco Dipped Products Pvt., Ltd. | KGO | Class I | |
| K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | ArthroCare Corporation | GEI | Class II | |
| K000771 | Dimax 2 | Planmeca Oy | EHD | Class II | |
| K000745 | Sensi Grip Latex Examination Glove, Powdered Contains 200 Mcgm or Less of Total Water Extractable Protein per Gram | Tillotson Healthcare Corp. | LYY | Class I | |
| K000681 | Au5, Au6 | Esaote North America, Inc | IYO | Class II | |
| K000579 | Tempo Aqua Angiographic Catheter | Cordis US Corp. | DQO | Class II | |
| K000547 | Atr Tecnika | Advanced Technology Research (A.T.R.) S.R.P. | EFB | Class I | |
| K000438 | Multi Lumen Suction Syringe Spray Dispenser | Biosurgical Corp. | FMF | Class II | |
| K000395 | Einstein Processing and Review Workstation | GE Medical Systems F.I. Haifa | LLZ | Class II | |
| K000380 | Fotomaster | Hamilton Thorne Research | LLZ | Class II | |
| K000349 | Motorized Micro Multileaf Collimator | Stryker Leibinger | IXI | Class II | |
| K000348 | Colorado Microdissection Needle | Stryker Leibinger | GEI | Class II | |
| K000333 | Standard & Extended Blade, Standard & Extended Needle, Standard & Extended Ball, Modified Standard & Extended Blade, Mod | Triad Surgical Technologies, Inc. | JOS | Class II | |
| K000140 | Clini-Dent | The Precident Group | MAU | Class I | |
| K994380 | Cedia Dau Amphassure Assay | Microgenics Corporation | DKZ | Class II | |
| K982101 | Shelhigh No-React Dura Shield | Shelhigh, Inc. | GXQ | Class II | |
| K001266 | Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitamin B12/folate Reagent Pack 3, Products Red Cell Folate Pa | Ortho-Clinical Diagnostics, Inc. | CGN | Class II | |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator Kits | Elan Holdings, Inc. | CHH | Class I | |
| K000781 | Direct Tibc Kit | Reference Diagnostics, Inc. | JMO | Class I | |
| K000672 | Heliodent Vario | Sirona Dental Systems GmbH | EHD | Class II | |
| K000665 | Tfx Medical Safety Needle with Introducer | Tfx Medical, Inc. | FOZ | Class II | |
| K000663 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | GCJ | Class II | |
| K000545 | Sentry Expanding Introducer Sheath (Eis) | Applied Medical Resources Corp | GCJ | Class II | |
| K000480 | Active Electrode Monitoring System | Electroscope, Inc. | GEI | Class II | |
| K000327 | Wavescan Wavefront System Model Hs 1 | Visx, Incorporated | HKO | Class I | |
| K000320 | Sonos Aires 600 (Sa-600) | Kpi Ultrasound, LLC | IYO | Class II | |
| K001132 | Bone Biopsy Needle | Promex, Inc. | KNW | Class II | |
| K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc | DQA | Class II | |
| K001079 | Recumbent Bathing Systems, Rhapsody and Primo | Arjo, Inc. | ILJ | Class II | |
| K000982 | A100 Aesthetic Diode Laser | Diomed, Inc. | GEX | Class II | |
| K000682 | Synthes Large Fragment Dynamic Compression Locking (Dcl) System | Synthes (USA) Products LLC | KTT | Class II | |
| K000519 | Glucanpro | Brennen Medical, Inc. | MGQ | Unclassified | |
| K000518 | Macropro Gel | Brennen Medical, Inc. | MGQ | Unclassified | |
| K000506 | Bio-Fastak Suture Anchor, Model Ar-1324B | Arthrex GmbH | MAI | Class II | |
| K994372 | Model 120 | Palco Labs, Inc. | DQA | Class II | |
| K993756 | Health-Plus, Sanitex, Reliance Sterile Powder-Free Nitrile Surgical Gloves | Pamitex Industries Sdn Bhd | KGO | Class I | |
| K993619 | Csecure Combined Spinal/epidural Anesthesia System with Lock | Abbott Medical | BSP | Class II |