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 |
|---|---|---|---|---|---|
| K832889 | Amylase | Horiba Instruments Incorporated | JFJ | Class II | |
| K832795 | Heifetz Intracranial Aneurysm Clips | Edward Weck, Inc. | HCH | Class II | |
| K832746 | Dupont Linearization Module | E.I. Dupont de Nemours & Co., Inc. | JQP | Class I | |
| K832510 | Evoked Potentials System Mk10 | Amplaid USA, Inc. | GWJ | Class II | |
| K832345 | Polystyrene Microtiter Well Immunosor | Diagnostic Reagent Tech. | DGC | Class II | |
| K831438 | Elastoplast | Beiersdorf, Inc. | FPX | Class I | |
| K833910 | Tsh Ria | Syncor Intl. Corp. | ETD | Class II | |
| K832988 | Staodyn Ems/plus | Staodynamics, Inc. | IPF | Class II | |
| K832935 | Gasline Filter, #Ec-Glf Series | Gish Biomedical, Inc. | CAH | Class II | |
| K831819 | Oxygen Concentrator Respiratory Suppor | Eagle Medical Equipment Co. | CAW | Class II | |
| K823910 | Donaldson Vent Tube | Treace Medical, Inc. | ETD | Class II | |
| K833909 | Ventrescreen Beta-Hcg Enzyme Immuno | Vxr, Inc. | ETD | Class II | |
| K833615 | Hearing Aid Unitron Ui3 | Unitron Industries, Inc. | ESD | Class I | |
| K833614 | Hearing Aid, Unitron Ut1 | Unitron Industries, Inc. | ESD | Class I | |
| K833530 | Digital Fluorographic X-Ray System | General Electric Co. | JAA | Class II | |
| K833525 | Cemax-1000 | Contour Medical Systems, Inc. | LMB | Class I | |
| K833523 | C.b. Radiology Design Gonadshield | Radiology Design | IWT | Class I | |
| K833463 | Clex | Dextran Products, Ltd. | KIS | Class I | |
| K833450 | Nuk Breast Shield | Reliance Products Corp. | HFS | Class I | |
| K833239 | Porta. X-Ray Unit Fp220 Scm-1-Etc, | Showa X-Ray Co., Ltd. | IZL | Class II | |
| K833230 | Registrex 1000 Digital Radiography Sys | Advanced Technology Laboratories, Inc. | JAA | Class II | |
| K833172 | ECG-Gel Electrode Gel | Whs Products, Inc. | GYB | Class II | |
| K833148 | Enzyme Ana Test System | IMMUNO CONCEPTS, NA, Ltd. | LJM | Class II | |
| K833135 | Intracath Intravenous Catheter Unit | Parke-Davis Co. | FOZ | Class II | |
| K833129 | Tago Diffu-Gen-Apolipoprotein B-100 | Tago, Inc. | MSJ | Class I | |
| K833119 | Autoimmune Test 1/2/3 System | Atlantic Antibodies | DHN | Class II | |
| K833113 | Reporting Integrator 3392A | Hewlett-Packard Co. | LDM | Class I | |
| K833092 | Deseret Angio-Guide Large Vein Cath. | Warner-Lambert Co. | FOZ | Class II | |
| K833091 | Deseret Subclavian Jugular Cath-Set | Warner-Lambert Co. | FOZ | Class II | |
| K833076 | C-Flex Medical Grade Tubing | Concept, Inc. | FPK | Class II | |
| K832922 | Travaspore Biological Indicator | Travenol Laboratories, S.A. | FRC | Class II | |
| K832864 | Coloscreen V.p.i. | Helena Laboratories, Corp. | KHE | Class II | |
| K832642 | Alpha-I | Johnson Flexgroup | LHC | Class I | |
| K832633 | Innovative Hearing Corp. #Ihc 1000 | Innovative Hearing Corp. | ESD | Class I | |
| K832624 | Top Venula i.v. Catheter Set | Top Surgical Manufacturers Co. | FOZ | Class II | |
| K832591 | Diacrom *Plg | Wellcome Diagnostics | DDX | Class I | |
| K832405 | Opthalmic Endoscope | Cilco, Inc. | |||
| K832344 | Polystyrene Microtiter Plate Immuno- | Diagnostic Reagent Tech. | DHB | Class II | |
| K832168 | Personal Amplifier | Electone, Inc. | ESD | Class I | |
| K831984 | Polystyrene Micro-Liter Plate-Birchtree | Diagnostic Reagent Tech. | DGO | Class II | |
| K831447 | Capnometer W/new Airway Adapter 47210A | Hewlett-Packard Co. | CCK | Class II | |
| K832702 | Pocket Aid | M.C. Johnson Co., Inc. | LDR | Class II | |
| K832131 | Servomed Central Station Smv 206 | Litton Medical Electronics | DRT | Class II | |
| K832035 | Servomed Compact Monitor Smk 155-9 | Litton Medical Electronics | DRT | Class II | |
| K832022 | Servomed Smc 108/111-426-24, 111-426 | Litton Medical Electronics | DXJ | Class II | |
| K832021 | Servomed Compact Monitor Smk 154-8/101 | Litton Medical Electronics | DRT | Class II | |
| K831783 | Servomed Basic Bedside Unit Smv 104 | Litton Medical Electronics | DXJ | Class II | |
| K831782 | Servomed Basic Bedside Unit Smv 107 | Litton Medical Electronics | DXJ | Class II | |
| K831781 | Servomed Basic Bedside Unit Smviii W | Litton Medical Electronics | DXJ | Class II | |
| K833150 | Asahi Hollow Fiber Kidneys, Excel | Asahi Kasei Medical MT Corp. Oita Works | KOC | Class II |