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 |
|---|---|---|---|---|---|
| K912481 | Ect Carbon Fiber Pallet, Modification | Siemens Gammasonics, Inc. | IYZ | Class I | |
| K912352 | Peace Model 100 Cuff Monitor | Peace Medical, Inc. | BSK | Class II | |
| K912286 | Cardiac Spect Pallet | Siemens Gammasonics, Inc. | IYZ | Class I | |
| K912092 | Modified Lifecare Model 175 Infuser | Abbott Medical | FRN | Class II | |
| K912022 | Frastec Drynet, Bridal Veil, Various Sizes | Fraass Survival Systems, Inc. | NAD | Class I | |
| K911985 | Lumatag T4 Chemiluminescence Assay | London Diagnostics, Inc. | CDX | Class II | |
| K911964 | Modified Pancretec Provider One Infusion System | Abbott Medical | FRN | Class II | |
| K911938 | Dynavision 2000 | Performance Ent. | LQD | Unclassified | |
| K911815 | 3Rd Hand Helper | Apyx Medical Corporation | FPA | Class II | |
| K911637 | Stayfree, Unscented/scented/scented Deodor Men Pad | Personal Products Co. | HAD | Class II | |
| K911567 | Dual Compartment Tpn Bag 3 Liter | Stedim, Inc. | KPE | Class II | |
| K911521 | Arthrobot(tm) 96 (240 Cm) Drape with 1 Strap | Andronic Devices, Ltd. | KKX | Class II | |
| K911520 | Arthrobot(tm) 75 (190 Cm) General Purpose Drape | Andronic Devices, Ltd. | KKX | Class II | |
| K911264 | Calibration Kit | S & W Medico Teknik | BXK | Class I | |
| K911193 | Ohmeda Model 4700 Oxicap | GE Healthcare | CCK | Class II | |
| K910950 | Hms-4000 Multichannel Physio Monit Syst, Modified | Vitalog Monitoring,Inc. | BZG | Class II | |
| K910926 | Tecnadyne Surgi-Squeeze Infusion Pump | Tecnadyne Scientific, Inc. | KZD | Class I | |
| K910917 | Cathlab Silicone Biliary Balloon Catheter | Cathlab Corp. | GCA | Class II | |
| K904926 | Smart-Ep | Intelligent Hearing Systems Corp. | GWJ | Class II | |
| K913233 | Codman Lhalo Split Ring Retractor System | Cerenovus, Inc. | GZT | Class II | |
| K913104 | Monoscopy(tm) Brand, Electrosurgical Rake | Dexide, Inc. | GCJ | Class II | |
| K912884 | E.t. Tape II | B & B Medical Technologies, Inc. | CBH | Class I | |
| K912870 | Hearing Aid, Unitron Model Uik | Unitron Industries, Inc. | ESD | Class I | |
| K912582 | Magic Lite Sq Specific Ige Immunoassay System | Ciba Corning Diagnostics Corp. | DHB | Class II | |
| K912011 | Codman Skull Clamp | Cerenovus, Inc. | HBL | Class II | |
| K911956 | Zoll Pd-1400 Pacer/defibrillator | Zmi Corp. | DRO | Class II | |
| K911896 | Devilbiss Model 5000 | Devilbiss Health Care, Inc. | CAF | Class II | |
| K911752 | Icon Teleradiology System | Icon Medical Systems, Inc. | LLZ | Class II | |
| K911090 | Omega Angioscopes (Omegascopes) | Omega Universal Technologies, Ltd. | LYK | Class II | |
| K913066 | Emit(r) 2000 Carbamazepine Assay/calibrators | Syva Co. | KLT | Class II | |
| K912938 | Rhythm | Stellate Systems | GWS | Class I | |
| K912917 | Milenia Estradiol | Siemens Healthcare Diagnostics Inc. | CHP | Class I | |
| K912912 | Synermed Serum Iron-600 Reagent Kit | Synermed, Inc. | CFM | Class I | |
| K912858 | London Diagnostics Lumatag(r) Hgh Chem Immun Assay | London Diagnostics, Inc. | CFL | Class I | |
| K912831 | Bacti-Swab(tm) II | Remel Inc | LIO | Class I | |
| K912810 | Abbott Quickstart Total Protein Test Item# 5A13 | Em Diagnostic Systems, Inc. | CEK | Class II | |
| K912808 | Abbott Quick Start Glucose (Glue) Item# 5A15 | Em Diagnostic Systems, Inc. | CFR | Class II | |
| K912725 | Total Iron & Unsat Iron Bind Cap/iron Bind Control | Creative Laboratory Products, Inc. | JJY | Class I | |
| K912603 | Rep Alp-15, 8, & 4 Kits | Helena Laboratories, Corp. | CIN | Class II | |
| K912596 | Meconium Aspiration | Pacific Device, Inc. | BSY | Class I | |
| K912587 | K-Free | Katecho LLC | LDD | Class II | |
| K912497 | Ionobond | Voco GmbH | EMA | Class II | |
| K912495 | Ionoseal | Voco GmbH | EJK | Class II | |
| K912465 | Vital-Port Dual Lumen Vascular Access System 1121 | Med Institute, Inc. | LJT | Class II | |
| K912434 | Salter Labs Infant Nasal CPAP Cannula | Salter Labs | BZD | Class II | |
| K912424 | Vital-Port Vascular Access System 7010 and 7110 | Med Institute, Inc. | LJT | Class II | |
| K912423 | Vital-Port m.r.i. Vascular Access System 7012,7112 | Med Institute, Inc. | LJT | Class II | |
| K912346 | Medikeeper | Medikeeper, Inc. | BRY | Class I | |
| K912292 | Diastat Anti-Jo-1 Kit | Shield Diagnostics, Ltd. | DHN | Class II | |
| K912291 | Distat Anti-Scl-70 Kit | Shield Diagnostics, Ltd. | LKJ | Class II |