Cleared Traditional

K001708 - PROFOX SOFTWARE, MODEL 920M-41

K001708 is an FDA 510(k) clearance for PROFOX SOFTWARE, manufactured by Respironics Georgia, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K001708 · Respironics Georgia, Inc. · Anesthesiology device
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Mar 2001
Decision
269d
Days
Class 2
Risk

K001708 is an FDA 510(k) clearance for the PROFOX SOFTWARE, MODEL 920M-41. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Respironics Georgia, Inc. (Marietta, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 269 days - an extended review 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: 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 Respironics Georgia, Inc. devices

FDA 510(k) Submission Details - K001708

510(k) Number K001708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date March 01, 2001
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 140d · This submission: 269d
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 563
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K001708.
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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