Cleared Traditional

K182235 - OnSite Waste Sharps Container (FDA 510(k) Clearance)

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

K182235 · Bluestone Medical, Inc. · General Hospital
May 2019
Decision
276d
Days
Class 2
Risk

K182235 is an FDA 510(k) clearance for the OnSite Waste Sharps Container. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Bluestone Medical, Inc. (East Hampton, US). The FDA issued a Cleared decision on May 20, 2019 after a review of 276 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.

Submission Details

510(k) Number K182235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2018
Decision Date May 20, 2019
Days to Decision 276 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 169d · This submission: 276d
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

Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K182235.
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
Promisemed Sharps container
K211890 · Promisemed Hangzhou Meditech Co., Ltd. · Nov 2021