Cleared Traditional

K152340 - NAR Sharps Shuttle (FDA 510(k) Clearance)

Also includes:
NAR Sharps Shuttle Pack of six

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

K152340 · North American Rescue, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
286d
Days
Class 2
Risk

K152340 is an FDA 510(k) clearance for the NAR Sharps Shuttle. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by North American Rescue, LLC (Greer, US). The FDA issued a Cleared decision on May 31, 2016 after a review of 286 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all North American Rescue, LLC devices

Submission Details

510(k) Number K152340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date May 31, 2016
Days to Decision 286 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 128d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K152340.
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · Pureway Compliance, Inc. · Oct 2025
Community Containers (Flap and Daisy)
K252637 · Keter Canada, Inc. · Oct 2025
PureWay 1.4 Quart Sharps Collector
K231484 · Pureway Compliance, Inc. · Sep 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023
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