Cleared Traditional

K955520 - RESCUE BREATHER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955520 · International Safety, Inc. · Anesthesiology device
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Oct 1996
Decision
309d
Days
Class 2
Risk

K955520 is an FDA 510(k) clearance for the RESCUE BREATHER. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by International Safety, Inc. (Eugene, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 International Safety, Inc. devices

Submission Details

510(k) Number K955520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date October 08, 1996
Days to Decision 309 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 139d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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.