Cleared Traditional

K962869 - GSP1 - GAS SELECTION PANEL

K962869 is an FDA 510(k) clearance for GSP1 - GAS SELECTION PANEL, manufactured by Reimers Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K962869 · Reimers Systems, Inc. · Anesthesiology device
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Oct 1996
Decision
92d
Days
Class 2
Risk

K962869 is an FDA 510(k) clearance for the GSP1 - GAS SELECTION PANEL. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Reimers Systems, Inc. (Springfield, US). The FDA issued a Cleared decision on October 23, 1996 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - 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 Reimers Systems, Inc. devices

FDA 510(k) Submission Details - K962869

510(k) Number K962869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1996
Decision Date October 23, 1996
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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 - CBF Chamber, Hyperbaric

All 10
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