Cleared Traditional

K962848 - HANS RUDOLPH NASAL CPAP MASK

K962848 is an FDA 510(k) clearance for HANS RUDOLPH NASAL CPAP MASK, manufactured by Hans Rudolph, Inc.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K962848 · Hans Rudolph, Inc. · Anesthesiology device
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Oct 1996
Decision
86d
Days
Class 1
Risk

K962848 is an FDA 510(k) clearance for the HANS RUDOLPH NASAL CPAP MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 86 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 Hans Rudolph, Inc. devices

FDA 510(k) Submission Details - K962848

510(k) Number K962848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date October 16, 1996
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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 20
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K962848.
SEAL RING FOR NASAL CPAP
K921499 · Devilbiss Health Care, Inc. · Sep 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