Cleared Abbreviated

AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. (K071517) - FDA 510(k) Clearance

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

K071517 · A.B.M. Italia S.P.A · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
303d
Days
Class 2
Risk

K071517 is an FDA 510(k) clearance for the AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by A.B.M. Italia S.P.A (Roncadelle Di Ormelle, IT). The FDA issued a Cleared decision on April 2, 2008 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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 A.B.M. Italia S.P.A devices

Submission Details

510(k) Number K071517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date April 02, 2008
Days to Decision 303 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 129d · This submission: 303d
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 112
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K071517.
Guanhong Sharps Container (GHW-1F1)
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Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
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PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
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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