Cleared Traditional

K935126 - NASCOR IGLOO (FDA 510(k) Clearance)

Class I Anesthesiology device.

K935126 · Nascor Pty. , Ltd. · Anesthesiology device
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Oct 1994
Decision
355d
Days
Class 1
Risk

K935126 is an FDA 510(k) clearance for the NASCOR IGLOO. Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Nascor Pty. , Ltd. (Sydney Nsw, AU). The FDA issued a Cleared decision on October 18, 1994 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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. Elevated predicate reliance profile. 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 Nascor Pty. , Ltd. devices

Submission Details

510(k) Number K935126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date October 18, 1994
Days to Decision 355 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
216d slower than avg
Panel avg: 139d · This submission: 355d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.