Cleared Abbreviated

K213274 - Qlicksmart BladeFlask UNIVERSAL (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K213274 · Qlicksmart Pty , Ltd. · General Hospital
Download Printable Device Report (PDF)
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Jun 2022
Decision
265d
Days
Class 2
Risk

K213274 is an FDA 510(k) clearance for the Qlicksmart BladeFlask UNIVERSAL. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Qlicksmart Pty , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on June 22, 2022 after a review of 265 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Qlicksmart Pty , Ltd. devices

Submission Details

510(k) Number K213274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date June 22, 2022
Days to Decision 265 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 128d · This submission: 265d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 Hospital devices follow this clearance model.

Regulatory Peers - MMK Container, Sharps

All 111
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K213274.
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Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
K222905 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023