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 |
|---|---|---|---|---|---|
| K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | DWF | Class II | |
| K182252 | Cook Unimpregnated Central Venous Catheter | Cook Incorporated | FOZ | Class II | |
| K173570 | SD Abutment | Surgident Co., Ltd. | NHA | Class II | |
| K191051 | Argos | Santec Corporation | MXK | Class II | |
| K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | LLZ | Class II | |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix Ltd. | IYN | Class II | |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K190472 | Aptima CV/TV Assay | Hologic, Inc. | PQA | Class II | |
| K190372 | Aveta System | Meditrina, Inc. | HIH | Class II | |
| K190355 | Precision Casting Solutions Total Knee System | Precision Casting Solutions, Inc. | JWH | Class II | |
| K190345 | Vpc | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | Unicon Optical Co., Ltd. | LPL | Class II | |
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. | JWH | Class II | |
| K173895 | Tel-O-Graph | I.E.M. Industrielle Entwicklung and Medizintechnik | DXN | Class II | |
| K190639 | Endosee System | CooperSurgical, Inc. | HIH | Class II | |
| K190584 | CAYMAN LP Plate System | K2M, Inc | KWQ | Class II | |
| K190493 | Recovery Pump, 737R (RPX) | MEGO AFEK AC Ltd. | IRP | Class II | |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | MDB | Class I | |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | PDZ | Class II | |
| K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | MWI | Class II | |
| K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems Limited | PPU | Class II | |
| K183292 | Topaz Mobile DR System | DRGEM Corporation | IZL | Class II | |
| K183277 | SpO2 Sensor | Shenzhen Upnmed Equipment Co., Ltd. | DQA | Class II | |
| K182602 | SOFIA EX Intracranial Support Catheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K182532 | Liba3 System | National Cardiac, Inc. | DSI | Class II | |
| K182520 | Flexible Overtube | Sumitomo Bakelite Co., Ltd. | FED | Class II | |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | Olympus Medical Systems Corp. | KNS | Class II | |
| K182328 | VeriClear Digital Early Result Pregnancy Test | True Diagnostics, Inc. | LCX | Class II | |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | FCX | Class II | |
| K190974 | D'Vill Introducer | Numed Inc | DYB | Class II | |
| K190848 | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K190670 | ORTHOLOC™ 2 Lapidus with Rotation System | Wrightmedicaltechnologyinc | HRS | Class II | |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | Phadia AB | DHB | Class II | |
| K190297 | Celerity HP Incubator | STERIS Corporation | FRC | Class II | |
| K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead de LLC | KTT | Class II | |
| K181419 | Flix-Ems | Casgarum Investment, S.L. | NGX | Class II | |
| K190764 | SurgicalAR | Medivis, Inc. | LLZ | Class II | |
| K190604 | Pivo | Becton Dickinson Infusion Therapy Systems Inc. | JKA | Class II | |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | DiaSorin Molecular LLC | PLO | Class II | |
| K190170 | MVP Cervical Plate System | GS Medical Co., Ltd. | KWQ | Class II | |
| K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | OWB | Class II | |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | HBC | Class II | |
| K182180 | SPEAC System | Brain Sentinel, Inc. | POS | Class II | |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker Corp. | OWN | Class II | |
| K190995 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | IYN | Class II | |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote S.p.A. | IYN | Class II | |
| K190854 | Therm-X | Zenith Technical Innovations, LLC | IRP | Class II | |
| K190275 | GenePOC Carba | Genepoc, Inc. | PMY | Class II | |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | Jk-Holding GmbH | LEJ | Class II |