Cleared Traditional

K080845 - ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

K080845 is an FDA 510(k) clearance for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM, manufactured by Cardinalhealth. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K080845 · Cardinalhealth · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
35d
Days
Class 2
Risk

K080845 is an FDA 510(k) clearance for the ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on April 30, 2008 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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.

View all Cardinalhealth devices

FDA 510(k) Submission Details - K080845

510(k) Number K080845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2008
Decision Date April 30, 2008
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
NED DEVINE

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 - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 43
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K080845.
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K103535 · Apex Medical Corp. · Feb 2011
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
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EMG MODEL SUA01 SUCTION UNIT
K042349 · Emg Technology Co., Ltd. · Dec 2004
DEVILBISS SUCTION UNIT
K982304 · Sunrise Medical Hhg, Inc. · Sep 1998

FDA 510(k) Resources - General & Plastic Surgery

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