Cleared Traditional

K012891 - OXIMAX PULSE OXIMETRY SYSTEM WITH N-595...

K012891 is an FDA 510(k) clearance for OXIMAX PULSE OXIMETRY SYSTEM WITH N-595..., manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K012891 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Mar 2002
Decision
191d
Days
Class 2
Risk

K012891 is an FDA 510(k) clearance for the OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on March 7, 2002 after a review of 191 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 Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K012891

510(k) Number K012891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2001
Decision Date March 07, 2002
Days to Decision 191 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 140d · This submission: 191d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K012891.
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