Cleared Traditional

K091690 - SHARP CHUTE

K091690 is an FDA 510(k) clearance for SHARP CHUTE, manufactured by Heathrow Scientific, LLC. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K091690 · Heathrow Scientific, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
48d
Days
Class 2
Risk

K091690 is an FDA 510(k) clearance for the SHARP CHUTE. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Heathrow Scientific, LLC (Vernon Hills, US). The FDA issued a Cleared decision on July 28, 2009 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K091690

510(k) Number K091690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date July 28, 2009
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMK Container, Sharps

All 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K091690.
SHARPS CONTAINER
K110262 · Noble Marketing · Apr 2011
SHARPS CONTAINER
K101567 · Cixi Leinuo Plastic Co., Ltd. · Sep 2010
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · Daniels Corporation Pty, Inc. · Oct 2009
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · Wcm Waste & Compliance Management, Inc. · May 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · Industrial Water Solutions, Inc. · Mar 2009
SHARPS COMPLIANCE CONTAINER
K083129 · Sharps Compliance, Inc. · Dec 2008

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K091690 · SHARP CHUTE
Download PDF FDA Summary Heathrow Scientific, …