Cleared Traditional

K904988 - PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

K904988 is the FDA 510(k) clearance for PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR by Palco Laboratories, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K904988 · Palco Laboratories, Inc. · Anesthesiology device
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Mar 1991
Decision
131d
Days
Class 2
Risk

K904988 is an FDA 510(k) clearance for the PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Palco Laboratories, Inc. (Santa Cruz, US). The FDA issued a Cleared decision on March 18, 1991 after a review of 131 days - within the typical 510(k) review window.

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. 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 Palco Laboratories, Inc. devices

Submission Details

510(k) Number K904988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date March 18, 1991
Days to Decision 131 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 140d · This submission: 131d
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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K904988.
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
COROMETRICS MODEL 556 NEONATAL MONITOR
K900001 · Ge Medical Systems Information Technologies · Nov 1990
HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
K903523 · Hewlett-Packard Co. · Oct 1990
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · Cobe Laboratories, Inc. · Aug 1990