Cleared Traditional

K010577 - BODYGEM

K010577 is an FDA 510(k) clearance for BODYGEM, manufactured by Healthetech, Inc.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K010577 · Healthetech, Inc. · Anesthesiology device
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Jan 2002
Decision
317d
Days
Class 2
Risk

K010577 is an FDA 510(k) clearance for the BODYGEM, MODEL HB211. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Healthetech, Inc. (Los Gatos, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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. Elevated predicate reliance profile. 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 Healthetech, Inc. devices

FDA 510(k) Submission Details - K010577

510(k) Number K010577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date January 10, 2002
Days to Decision 317 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
177d slower than avg
Panel avg: 140d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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