Cleared Traditional

K894100 - OXYTRAK(TM) PULSE OXIMETER

K894100 is an FDA 510(k) clearance for OXYTRAK(TM) PULSE OXIMETER, manufactured by Critikon Company, LLC. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K894100 · Critikon Company, LLC · Anesthesiology device
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May 1990
Decision
334d
Days
Class 2
Risk

K894100 is an FDA 510(k) clearance for the OXYTRAK(TM) PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K894100

510(k) Number K894100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date May 09, 1990
Days to Decision 334 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
194d slower than avg
Panel avg: 140d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 457
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K894100.
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
ESCORT MODEL 300
K902060 · Medical Data Electronics · Jun 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · Mennen Medical, Inc. · May 1990
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · Novametrix Medical Systems, Inc. · Oct 1989