Cleared Traditional

K080845 - ORWELL FLUID COLLECTION AND DISPOSAL SY...

K080845 is the FDA 510(k) clearance for ORWELL FLUID COLLECTION AND DISPOSAL SY... by Cardinalhealth. It is a Class 2 General & Plastic Surgery device (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

Submission Details

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
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.

Device Classification

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

All 19
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K080845.
Stryker Neptune 3 Waste Management System
K153407 · Stryker Corporation · Apr 2016
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
K132671 · Stryker Corporation · Dec 2013
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc. · Oct 2012
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K060277 · Boehringer Laboratories · Mar 2006
VACPLUS
K945062 · Kinetic Concepts, Inc. · Mar 1995
ANNELID
K940886 · Kinetic Concepts, Inc. · Nov 1994