Decision Date2024-03-21
Product CodeFMK
Advisory CommitteeSU
DecisionUnknown
Device Summary
RedDrop ONE (One) is a medical device manufactured by Reddrop DX. It received FDA 510(k) clearance on 2024-03-21 under approval number K234081. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the RedDrop ONE (One)?
RedDrop ONE (One) is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by Reddrop DX. The 510(k) number is K234081.
When was RedDrop ONE (One) approved by the FDA?
RedDrop ONE (One) received FDA 510(k) clearance on 2024-03-21, under approval number K234081.
What company makes RedDrop ONE (One)?
RedDrop ONE (One) is manufactured by Reddrop DX.
What is the FDA product code for RedDrop ONE (One)?
The FDA product code for RedDrop ONE (One) is FMK.
Related Devices (Code: FMK)
K153670Genteel Lancing DeviceGenteel, LLC
K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd.
K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.
K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.
K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc.
K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel LancetsBecton, Dickinson and Company
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.