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 |
|---|---|---|---|---|---|
| K011852 | Dimension Haic Assay, Model Df105 | Siemens Healthcare Diagnostics Inc. | LCP | Class II | |
| K013524 | Trochanteric Dyax Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K013470 | Modification to M2376a Devicelink System | Philips North America LLC | MWI | Class II | |
| K013403 | Tri-Fix Spinal Fixation System | Endius, Inc. | MNI | Class II | |
| K013402 | Visulas 532S | Carl Zeiss, Inc. | GEX | Class II | |
| K013291 | Altair Model, Dei System (Diffractive Energy Imaging System) | Advanced Diagnostics, Inc. | NCS | Class II | |
| K013285 | Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15 | IMMUNO CONCEPTS, NA, Ltd. | MOB | Class II | |
| K013283 | Relisa Pr3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16 | IMMUNO CONCEPTS, NA, Ltd. | MOB | Class II | |
| K012882 | Bitem Angel Reline Kit, Bitem Laboratory Kit, Models 120110, 120060 | Thermoelastic Technologies, Inc. | EBI | Class II | |
| K012823 | Modification to Handmaster | Ness-Neuromuscular Electrical Stimulation Systems | GZI | Class II | |
| K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K012801 | N2000 Base Station, N2001 Nurse Station | Neptec Design Group, Ltd. | DXN | Class II | |
| K012771 | Trocar Sleeve and Accessories, Models 1287-Xx-Xx | Pajunk GmbH Medizintechnologie | GCJ | Class II | |
| K012751 | Healos Bone Graft Material | Orquest, Inc. | MQV | Class II | |
| K012750 | Adc Pediatric | Agfa Corp. | MQB | Class II | |
| K012746 | Ice Baton | Behive, Ltd. | LKX | Unclassified | |
| K012739 | Converge Acetabular System | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K012738 | Symphony Graft Delivery System (Gds) | Depuyacromed | GEY | Class I | |
| K011536 | Microstream O2/co2 Oral Nasal Filterline | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | IYO | Class II | |
| K013604 | Modification to: Ultralon (R) Powder Free Latex Surgical Gloves | Ansell Healthcare Products LLC | KGO | Class I | |
| K013603 | Modification To:micro Touch (R) Powder Free Latex Surgical Gloves , Model Style 65 | Ansell Healthcare Products LLC | KGO | Class I | |
| K013399 | Model Mes-9000/Emg System | Myotronics-Noromed, Inc. | HCC | Class II | |
| K013362 | Autoject 2 | Owen Mumford USA, Inc. | KZH | Class II | |
| K013207 | Tina-Quant Apolipoprotein B Ver.2 | Roche Diagnostics GmbH | DFC | Class II | |
| K013170 | Scantac Membrane or Scantac Strip | Sonotech, Inc. | ITX | Class II | |
| K013133 | Nordix Inc Rechargeable Battery Part Number 2116 | Nordix, Inc. | MOQ | Class I | |
| K013102 | Wiener Lab. Fer-Color Transferrina, Model Aux. Reagents for 25 Samples Cat. 1492002 | Wiener Laboratories Saic | JMO | Class I | |
| K013097 | Wiener Lab.fer-Color Aa, Model 5X 20 Ml Cat.n 1492003 | Wiener Laboratories Saic | JIY | Class I | |
| K013087 | Single Dose Dispensing Pin, Model 2201 | CareFusion 303, Inc | LHI | Class II | |
| K012815 | Safeskin Healthtouch Powder-Free Exam Glove with Vitamin E and Aloe | Kimberly-Clark Corporation | LYY | Class I | |
| K012753 | Soring Gmbh Sonoca 180/190 | Soring GmbH Medizintechnik | LFL | Unclassified | |
| K012718 | Modification to Corometrics Model 120Is Maternal/fetal Monitoring System. | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K011048 | Bsm Bone Substitute Material | Depuy Orthopaedics Inc. | MQV | Class II | |
| K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257 | Heinz Kurz GmbH Medizintechnik | ETB | Class II | |
| K013548 | Standard Imaging Ivb 1000 Well Chamber | Standard Imaging Inc. | KPT | Class II | |
| K013497 | Fas Set #4551 | Gynetics Medical Products NV | MQE | Class II | |
| K013393 | Heparin Coated Miniature Centrifugal Bypass Pump System;model #Cp-1H | A-Med Systems, Inc. | KFM | Class II | |
| K013372 | Clearblue Easy Early Result Pregnancy Test | Unipath, Ltd. | LCX | Class II | |
| K013152 | Atac Pak Direct Hdl Reagent and Atac Direct Hdl Calibrator Kits | Elan Holdings, Inc. | LBS | Class I | |
| K013126 | N Lp(a) Standard Sy | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K013114 | Bcs System | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K012964 | 56Mm Condom,male Natural Rubber Latex Condom | Innolatex Sdn. Bhd | HIS | Class II | |
| K012962 | Dotted Condom, Male Natural Rubber Latex Condom | Innolatex Sdn. Bhd | HIS | Class II | |
| K012951 | Apn-2 USA Series Flexible Choledochoscope | Circon Video | FGB | Class II | |
| K012824 | Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device | Acon Laboratories, Inc. | DIS | Class II | |
| K012698 | Vanguard Reprocessed Phacoemulsification | Stryker Sustainability Solutions | NKX | Class II | |
| K012672 | Boss-2000-2 Vacuum Erection Device | Pos-T-Vac, LLC | LKY | Class II | |
| K012670 | Boss 2000-3 Vacuum Erection Device | Pos-T-Vac, LLC | LKY | Class II | |
| K012665 | Ultra Thin Male Latex Condom with Silicone Lubricant | Innolatex Sdn. Bhd | HIS | Class II |