Cleared Traditional

K954480 - CONDENSATE COLLECTION KIT

K954480 is an FDA 510(k) clearance for CONDENSATE COLLECTION KIT, manufactured by Nova-Ventrx. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K954480 · Nova-Ventrx · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
94d
Days
Class 1
Risk

K954480 is an FDA 510(k) clearance for the CONDENSATE COLLECTION KIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Nova-Ventrx (Northbrook, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova-Ventrx devices

FDA 510(k) Submission Details - K954480

510(k) Number K954480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1995
Decision Date December 29, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K954480.
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K952014 · Prima, Inc. · May 1995
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K952016 · Prima, Inc. · May 1995
PRIMA MAPLESON D CIRCUIT
K952017 · Prima, Inc. · May 1995
PRIMA COAXIAL CIRCUITS
K952018 · Prima, Inc. · May 1995
PRIMA ADULT GAS SAMPLING CIRCUITS
K952019 · Prima, Inc. · May 1995
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · Prima, Inc. · May 1995