Cleared Traditional

K960401 - ULTIMATE SEAL

K960401 is an FDA 510(k) clearance for ULTIMATE SEAL, manufactured by Hans Rudolph, Inc.. The device is a Class 1 Anesthesiology device with product code KGB cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K960401

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
3d slower than avg
Panel avg: 140d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

KGB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KGB Mask, Oxygen, Non-rebreathing

Devices cleared under the same product code (KGB) and FDA review panel - the closest regulatory comparables to K960401.
CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
K935917 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
COMPACT MASK
K932347 · Vital Signs, Inc. · Jan 1994
OXYGEN MASK W/RESERVOIR BAG
K790161 · Airlife, Inc. · Apr 1979
OXYGEN MASK, CONCENTRATION AEROSOL MASK
K790162 · Airlife, Inc. · Apr 1979