Cleared Traditional

K914335 - STRAP, HEAD, GAS MASK

K914335 is an FDA 510(k) clearance for STRAP, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code BTK cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K914335 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
188d
Days
Class 1
Risk

K914335 is an FDA 510(k) clearance for the STRAP, HEAD, GAS MASK. Classified as Strap, Head, Gas Mask (product code BTK), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on April 2, 1992 after a review of 188 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5560 - 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K914335

510(k) Number K914335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date April 02, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 140d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

BTK Device Classification - Class 1, General Controls

Product Code BTK Strap, Head, Gas Mask
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5560
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.