Cleared Traditional

K854458 - CUSHION-FLEX TM-CPAP FACE MASK

K854458 is the FDA 510(k) clearance for CUSHION-FLEX TM-CPAP FACE MASK by Life Design Systems, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K854458 · Life Design Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
70d
Days
Class 2
Risk

K854458 is an FDA 510(k) clearance for the CUSHION-FLEX TM-CPAP FACE MASK. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 15, 1986 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 K854458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1985
Decision Date January 15, 1986
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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.

Regulatory Peers - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 21
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K854458.
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · Ohmeda Medical · Apr 1988
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · Puritan Bennett Corp. · Sep 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · Respironics, Inc. · May 1985
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · Respironics, Inc. · Dec 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · Ohmeda Medical · Nov 1984