Cleared Traditional

SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER (K884329) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
76d faster than avg
Panel avg: 139d · 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 145
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K884329.
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
K903523 · Hewlett-Packard Co. · Oct 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988