Cleared Traditional

K991617 - FACE-2-FACE CPR PROTECTION SHIELD (FDA 510(k) Clearance)

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

K991617 · Whiteline Plastics, Inc. · Anesthesiology device
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Nov 1999
Decision
177d
Days
Class 2
Risk

K991617 is an FDA 510(k) clearance for the FACE-2-FACE CPR PROTECTION SHIELD. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Whiteline Plastics, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on November 3, 1999 after a review of 177 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 Whiteline Plastics, Inc. devices

Submission Details

510(k) Number K991617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date November 03, 1999
Days to Decision 177 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
38d slower than avg
Panel avg: 139d · This submission: 177d
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.