Cleared Traditional

K875075 - RT-200 COMPUTER INTERFACE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K875075 · Timeter Instrument Corp. · Anesthesiology device
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Apr 1988
Decision
134d
Days
Class 1
Risk

K875075 is an FDA 510(k) clearance for the RT-200 COMPUTER INTERFACE. Classified as Calibrator, Pressure, Gas (product code BXX), Class I - General Controls.

Submitted by Timeter Instrument Corp. (Lancaster, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2620 - 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. Standard predicate reliance. 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 Timeter Instrument Corp. devices

Submission Details

510(k) Number K875075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date April 21, 1988
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 139d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXX Calibrator, Pressure, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2620
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.