Cleared Special

K002787 - MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120

K002787 is an FDA 510(k) clearance for MODEL 120, manufactured by Palco Labs, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 83-day FDA review.

K002787 · Palco Labs, Inc. · Anesthesiology device
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Nov 2000
Decision
83d
Days
Class 2
Risk

K002787 is an FDA 510(k) clearance for the MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Palco Labs, Inc. (Santa Cruz, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 83 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002787

510(k) Number K002787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2000
Decision Date November 29, 2000
Days to Decision 83 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K002787.
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K010419 · Masimo Corp. · Mar 2001
HOMMED SENTRY III PATIENT MONITOR SYSTEM
K004044 · Hommed, LLC · Mar 2001
PROFOX SOFTWARE, MODEL 920M-41
K001708 · Respironics Georgia, Inc. · Mar 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003167 · Masimo Corp. · Nov 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003244 · Masimo Corp. · Nov 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957 · General Electric Medical Systems Information Techn · Oct 2000
K002787 · MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
Download PDF Palco Labs, Inc.