Cleared Traditional

K921499 - SEAL RING FOR NASAL CPAP

K921499 is an FDA 510(k) clearance for SEAL RING FOR NASAL CPAP, manufactured by Devilbiss Health Care, Inc.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K921499 · Devilbiss Health Care, Inc. · Anesthesiology device
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Sep 1992
Decision
170d
Days
Class 1
Risk

K921499 is an FDA 510(k) clearance for the SEAL RING FOR NASAL CPAP. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 170 days - an extended review 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: 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 Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K921499

510(k) Number K921499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date September 17, 1992
Days to Decision 170 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
30d slower than avg
Panel avg: 140d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

BYG Device Classification - Class 1, General Controls

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.

Regulatory Peers - BYG Mask, Oxygen

All 22
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K921499.
TRACHEOSTOMY MASK
K913501 · B & F Medical Products, Inc. · Jan 1992
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · Salter Labs · Jul 1991
SLEEPAP MASK
K894642 · Medical Industries America, Inc. · Oct 1989
KENDALL CURITY OXYGEN MASK
K892434 · The Kendal Co. · Aug 1989
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K890193 · Puritan Bennett Corp. · Mar 1989
MASK, OXYGEN
K874092 · Life Support Products, Inc. · Feb 1988