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 |
|---|---|---|---|---|---|
| K192160 | EVO Platform | Quanta System Inc. | GEX | Class II | |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | Barco N.V. | PGY | Class II | |
| K191782 | TTC Phantom Intramedullary Nail System | Paragon 28 | HSB | Class II | |
| K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | HGX | Class II | |
| K191531 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | |
| K191528 | Venus Legacy Pro Device | Venus Concept USA Inc. | GEI | Class II | |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical | GZF | Class II | |
| K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd | OCX | Class II | |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp | HEW | Class II | |
| K191121 | Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens | Lentechs, LLC | LPL | Class II | |
| K191102 | Precision S 4K Sinuscope | Stryker Corp. | EOB | Class II | |
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | MVR | Class II | |
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | |
| K190250 | Microscope Navigation | Brainlab, Inc. | HAW | Class II | |
| K190213 | Yikang Endotracheal Tube | Jiangxi Yikang Medical Instrument Group Co., Ltd. | BTR | Class II | |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | Jiangsu Micsafe Medical Technology Co., Ltd | MEG | Class II | |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare Ltd. | DPW | Class II | |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | PSV | Class II | |
| K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | PENTAX of America, Inc. | EOQ | Class II | |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | Olympus Medical Systems Corp. | EOB | Class II | |
| K183027 | Steerable catheter control system | Stereotaxis Inc | PJB | Class II | |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K182751 | Reusable Temperature Probe | Shenzhen Caremed Medical Technology Co.,Ltd. | FLL | Class II | |
| K182355 | Secret RF Smartcure Applicator with electrodes | Ilooda Co,., Ltd. | GEI | Class II | |
| K181986 | Klinly Ultrasonic Tongue Cleaner | Kea Products, Ltd. | QIA | Class I | |
| K192148 | Freedom Primary PCK | Maxx Orthopedics Inc. | JWH | Class II | |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | Qingdao Hightop Biotech Co., Ltd. | LCX | Class II | |
| K192119 | 3M Clarity Aligners | 3M Company | NXC | Class II | |
| K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label | STERIS Corporation | JOJ | Class II | |
| K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K191625 | Persona Revision Knee System | Zimmer GmbH | JWH | Class II | |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | MED | Class II | |
| K191004 | Advocate Non-Contact Infrared Thermometer | Broadmaster Biotech Corporation | FLL | Class II | |
| K190930 | SmarTemp X1 | Parkell, Inc. | EBG | Class II | |
| K190899 | bili-hut | Little Sparrows Technologies Inc | LBI | Class II | |
| K190383 | GM501 Wash | HAMILTON THORNE, Inc. | MQL | Class II | |
| K183563 | Holinwon 30 | WONTECH Co., Ltd. | GEX | Class II | |
| K183433 | FUJIFILM Ultrasonic Endoscope | FUJIFILM Corporation | ODG | Class II | |
| K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | EOQ | Class II | |
| K192156 | Cartiva SCI instrumentation set | Cartiva, Inc. | QBO | Class II | |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | HRX | Class II | |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group Ltd. | CFN | Class II | |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC dba Golnit Sutures | NBY | Class II | |
| K191908 | MTS Imipenem 0.016-256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | OWB | Class II | |
| K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | GXY | Class II | |
| K191070 | Signia Small Diameter Reloads | Medtronic, Inc. | GDW | Class II | |
| K191034 | VPS Impression Material | Hygedent Inc. | ELW | Class II |