Cleared Traditional

K152521 - Seal Rite Non-Rebreathing Valve (FDA 510(k) Clearance)

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

K152521 · The Lifeguard Store, Inc. · Anesthesiology device
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Jun 2016
Decision
274d
Days
Class 2
Risk

K152521 is an FDA 510(k) clearance for the Seal Rite Non-Rebreathing Valve. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by The Lifeguard Store, Inc. (Normal, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 274 days - an extended review cycle.

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. 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 The Lifeguard Store, Inc. devices

Submission Details

510(k) Number K152521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date June 03, 2016
Days to Decision 274 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
135d slower than avg
Panel avg: 139d · This submission: 274d
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.