Cleared Traditional

K965239 - PIP LOW PROFILE SCAVENGING SYSTEM(260 A...

K965239 is an FDA 510(k) clearance for PIP LOW PROFILE SCAVENGING SYSTEM(260 A..., manufactured by Accutron, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K965239 · Accutron, Inc. · Anesthesiology device
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Mar 1997
Decision
87d
Days
Class 2
Risk

K965239 is an FDA 510(k) clearance for the PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGI.... Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Accutron, Inc. (Phoenix, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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: 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 Accutron, Inc. devices

FDA 510(k) Submission Details - K965239

510(k) Number K965239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date March 28, 1997
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBN Apparatus, Gas-scavenging

All 14
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