Cleared Traditional

K802417 - AB O2 CONSUMPTION CALCULATOR 980

K802417 is an FDA 510(k) clearance for AB O2 CONSUMPTION CALCULATOR 980, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802417 · Siemens Elema AB · Anesthesiology device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802417 is an FDA 510(k) clearance for the AB O2 CONSUMPTION CALCULATOR 980. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 17 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K802417

510(k) Number K802417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1980
Decision Date October 23, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
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.