Cleared Traditional

K904988 - PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

K904988 is an FDA 510(k) clearance for PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR, manufactured by Palco Laboratories, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K904988

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.

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 625
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K904988.
SATLITE PLUS PULSE OXIMETER
K905140 · Datex Division Instrumentarium Corp. · May 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
504US PULSE OXIMETER
K910770 · Criticare Systems, Inc. · May 1991
REFLECTANCE SENSOR (RS-10)
K904039 · Nellcor, Inc. · Dec 1990
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