Cleared Traditional

K960401 - ULTIMATE SEAL (FDA 510(k) Clearance)

Class I Anesthesiology device.

K960401 · Hans Rudolph, Inc. · Anesthesiology device
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Jun 1996
Decision
143d
Days
Class 1
Risk

K960401 is an FDA 510(k) clearance for the ULTIMATE SEAL. Classified as Mask, Oxygen, Non-rebreathing (product code KGB), Class I - General Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5570 - 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 Hans Rudolph, Inc. devices

Submission Details

510(k) Number K960401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date June 20, 1996
Days to Decision 143 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
4d slower than avg
Panel avg: 139d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGB Mask, Oxygen, Non-rebreathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5570
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.