Cleared Traditional

K843169 - CUSHION-FLEX TM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K843169 · Life Design Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
7d
Days
Class 1
Risk

K843169 is an FDA 510(k) clearance for the CUSHION-FLEX TM. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Life Design Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1984 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Life Design Systems, Inc. devices

Submission Details

510(k) Number K843169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date August 20, 1984
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 139d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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.