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 |
|---|---|---|---|---|---|
| K190224 | Medline Burn and Wound Dressing (OTC) | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K190206 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | HRX | Class II | |
| K190153 | RadiForce MX216 | Eizo Corporation | PGY | Class II | |
| K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | MQB | Class II | |
| K190039 | EchoSure Diagnostic Ultrasound System | Sonavex, Inc. | IYO | Class II | |
| K183448 | NewTom 5G XL | Cefla S.C. | JAK | Class II | |
| K183303 | Brainsway Deep TMS System | Brainsway Ltd. | QCI | Class II | |
| K183285 | cmTriage | Curemetrix, Inc. | QFM | Class II | |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | GXI | Class II | |
| K183092 | Kuros TLIF Cage | Kuros Biosciences BV | MAX | Class II | |
| K183085 | CoreDx™ Pulmonary Mini-Forceps | Boston Scientific Corporation | EOQ | Class II | |
| K182995 | Bariatric Power Positioning System (BPPS) | Motion Concepts LP | ITI | Class II | |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex GmbH | KWS | Class II | |
| K182537 | RADMAX Digital Imaging Software | DRGEM Corporation | LLZ | Class II | |
| K173064 | ZAPnea Oral Appliance | B. Fareid, Dds, PC | LRK | Class II | |
| K190184 | iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co Ltd | MQR | Class II | |
| K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | DYB | Class II | |
| K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | |
| K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | bioMerieux, Inc. | LON | Class II | |
| K183373 | Bonebridge | Med-el Elektromedizinische Geraete, GmbH | PFO | Class II | |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | VitalConnect, Inc. | DRG | Class II | |
| K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K182413 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | |
| K182344 | RhythmAnalytics | Biofourmis Singapore Pte., Ltd. | DQK | Class II | |
| K182311 | Cervella | Innovative Neurological Devices, LLC | QJQ | Class II | |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | DRT | Class II | |
| K180880 | DARI Health | Scientific Analytics, Inc. | LXJ | Class II | |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | Spectrum Spine Inc | MAX | Class II | |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | ODP | Class II | |
| K183366 | GenePOC Strep A | Genepoc, Inc. | PGX | Class II | |
| K183289 | ClearGrasp Snare | Finemedix | FDI | Class II | |
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | ETY | Class II | |
| K182966 | PLANET Onco Dose | Dosisoft | LLZ | Class II | |
| K182173 | Joule System | Sciton, Inc. | GEX | Class II | |
| K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc | LLZ | Class II | |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL | Class II | |
| K181682 | VISULAS green | Carl Zeiss Meditec Inc | HQF | Class II | |
| K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | FED | Class II | |
| K183172 | Stryker SternalPlate System | Stryker Corp. | HRS | Class II | |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | NEZ | Class II | |
| K182628 | Imagio Ultrasound Imaging System | Seno Medical Instruments, Inc. | IYN | Class II | |
| K181656 | ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) | Eyemed Technologies S.r.l. | LPL | Class II | |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical | LGZ | Class II | |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart SA | ODP | Class II | |
| K190193 | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II | |
| K183453 | Vs3-Ir | Medtronic, Inc. | OWN | Class II | |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant | United Consortium | NUC | Class II | |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics Inc. | MMI | Class II |