Cleared Traditional

K884329 - SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER

K884329 is the FDA 510(k) clearance for SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER by Baxter Healthcare Corp. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K884329 · Baxter Healthcare Corp · Anesthesiology device
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Dec 1988
Decision
63d
Days
Class 2
Risk

K884329 is an FDA 510(k) clearance for the SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 63 days - a notably fast clearance cycle.

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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K884329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date December 16, 1988
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 379
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K884329.
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