Cleared Traditional

K911191 - PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR

K911191 is an FDA 510(k) clearance for PALCO LABS MODEL 300 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 84-day FDA review.

K911191 · Palco Laboratories, Inc. · Anesthesiology device
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Jun 1991
Decision
84d
Days
Class 2
Risk

K911191 is an FDA 510(k) clearance for the PALCO LABS MODEL 300 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 June 10, 1991 after a review of 84 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 Palco Laboratories, Inc. devices

FDA 510(k) Submission Details - K911191

510(k) Number K911191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date June 10, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 K911191.
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
K911761 · S & W Medico Teknik · Oct 1991
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
MODEL 8604-FO PULSE OXIMETER
K910001 · Nonin Medical, Inc. · Jul 1991
503 PULSE OXIMETER
K911124 · Criticare Systems, Inc. · Jun 1991
SATLITE PLUS PULSE OXIMETER
K905140 · Datex Division Instrumentarium Corp. · May 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991