Cleared Traditional

K182235 - OnSite Waste Sharps Container

K182235 is an FDA 510(k) clearance for OnSite Waste Sharps Container, manufactured by Bluestone Medical, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K182235 · Bluestone Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Bluestone Medical, Inc. devices

FDA 510(k) Submission Details - K182235

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 129d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K182235.
Tiger Reusable Sharps Container
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Tiger Sharps Containers
K190240 · International Marketing Specialists, Inc. · May 2019
Maxcon Two Gallon Chemotherapy Container
K180983 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019
Maxcon Sharps Container
K180984 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019
HealthBeacon HB2 Sharps Bin
K172719 · Healthbeacon, Ltd. · May 2018