Cleared Traditional

Accu-Chek Safe-T-Pro Uno Lancing Device (K220364) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220364 · Roche Diabetes Care, Inc. · General & Plastic Surgery device
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Apr 2022
Decision
56d
Days
Class 2
Risk

K220364 is an FDA 510(k) clearance for the Accu-Chek Safe-T-Pro Uno Lancing Device. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Roche Diabetes Care, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 5, 2022 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diabetes Care, Inc. devices

Submission Details

510(k) Number K220364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2022
Decision Date April 05, 2022
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 63
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K220364.
Accu-Chek Safe-T-Pro Plus Lancing Device
K220849 · Roche Diabetes Care, Inc. · May 2022
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
K220917 · Gri-Alleset, Inc. · May 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · Tianjin Huahong Technology Co., Ltd. · May 2022
Heel Incision Safety Lancet
K210745 · SteriLance Medical (Suzhou), Inc. · Aug 2021
Promisemed Heel Blood Lancet
K193009 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2019