Cleared Special

K021605 - MEDGEM

K021605 is an FDA 510(k) clearance for MEDGEM, manufactured by Healthetech, Inc.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Special 510(k) pathway after a 29-day FDA review.

K021605 · Healthetech, Inc. · Anesthesiology device
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Jun 2002
Decision
29d
Days
Class 2
Risk

K021605 is an FDA 510(k) clearance for the MEDGEM. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Healthetech, Inc. (Golden, US). The FDA issued a Cleared decision on June 14, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Healthetech, Inc. devices

FDA 510(k) Submission Details - K021605

510(k) Number K021605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date June 14, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 - BZL Computer, Oxygen-uptake

All 14
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