Cleared Traditional

K970163 - ALPHA MX (20)/ULTRA PC (30)

K970163 is an FDA 510(k) clearance for ALPHA MX (20)/ULTRA PC (30), manufactured by Technical Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K970163 · Technical Medical Products, Inc. · Anesthesiology device
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Dec 1997
Decision
328d
Days
Class 2
Risk

K970163 is an FDA 510(k) clearance for the ALPHA MX (20)/ULTRA PC (30). Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Technical Medical Products, Inc. (Phoenix, US). The FDA issued a Cleared decision on December 10, 1997 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Technical Medical Products, Inc. devices

FDA 510(k) Submission Details - K970163

510(k) Number K970163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date December 10, 1997
Days to Decision 328 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 140d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 133
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