Cleared Traditional

K875075 - RT-200 COMPUTER INTERFACE

K875075 is an FDA 510(k) clearance for RT-200 COMPUTER INTERFACE, manufactured by Timeter Instrument Corp.. The device is a Class 1 Anesthesiology device with product code BXX cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K875075 · Timeter Instrument Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K875075

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

BXX Device Classification - Class 1, General Controls

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.

Regulatory Peers - BXX Calibrator, Pressure, Gas

Devices cleared under the same product code (BXX) and FDA review panel - the closest regulatory comparables to K875075.
UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
K850029 · Utah Medical Products, Inc. · Apr 1985
RT-200 CALIBRATION ANALYZER
K822746 · Timeter Instrument Corp. · Oct 1982
NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY
K801256 · Kleen Test Products · Jun 1980
NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.
K801257 · Kleen Test Products · Jun 1980
NEEDLE COUNTER-SURE COUNT/10 COUNT
K801258 · Kleen Test Products · Jun 1980