Cleared Traditional

K840264 - SERVO CART 170 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K840264 · Siemens Elema AB · Anesthesiology device
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Feb 1984
Decision
12d
Days
Class 1
Risk

K840264 is an FDA 510(k) clearance for the SERVO CART 170. Classified as Cart, Emergency, Cardiopulmonary (excluding Equipment) (product code BZN), Class I - General Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6175 - 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

Submission Details

510(k) Number K840264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date February 04, 1984
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 139d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZN Cart, Emergency, Cardiopulmonary (excluding Equipment)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.