Cleared Traditional

K912633 - SALTER LABS INFANT MEDIUM CONCENTRATION MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K912633 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
35d
Days
Class 1
Risk

K912633 is an FDA 510(k) clearance for the SALTER LABS INFANT MEDIUM CONCENTRATION MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Salter Labs devices

Submission Details

510(k) Number K912633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1991
Decision Date July 19, 1991
Days to Decision 35 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
104d faster than avg
Panel avg: 139d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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.