Cleared Traditional

K090157 - ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M

Also marketed or referenced as:
ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.

K090157 is an FDA 510(k) clearance for ISOLYSER HOME SHARPS MANAGEMENT (HSM), manufactured by Wcm Waste & Compliance Management, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K090157 · Wcm Waste & Compliance Management, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
102d
Days
Class 2
Risk

K090157 is an FDA 510(k) clearance for the ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Wcm Waste & Compliance Management, Inc. (Washington, US). The FDA issued a Cleared decision on May 4, 2009 after a review of 102 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K090157

510(k) Number K090157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date May 04, 2009
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K090157.
SHARPS CONTAINER
K101567 · Cixi Leinuo Plastic Co., Ltd. · Sep 2010
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · Daniels Corporation Pty, Inc. · Oct 2009
SHARP CHUTE
K091690 · Heathrow Scientific, LLC · Jul 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · Industrial Water Solutions, Inc. · Mar 2009
SHARPS COMPLIANCE CONTAINER
K083129 · Sharps Compliance, Inc. · Dec 2008
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · Zhejiang Gongdong Medical Plastic Factory · Sep 2008
K090157 · ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
Download PDF FDA Summary Wcm Waste & Complianc…