Cleared Special

K052186 - NELLCOR OXIMAX PULSE OXIMETRY SENSONS (...

K052186 is an FDA 510(k) clearance for NELLCOR OXIMAX PULSE OXIMETRY SENSONS (..., manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 91-day FDA review.

K052186 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Nov 2005
Decision
91d
Days
Class 2
Risk

K052186 is an FDA 510(k) clearance for the NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P. 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 November 10, 2005 after a review of 91 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K052186

510(k) Number K052186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2005
Decision Date November 10, 2005
Days to Decision 91 days
Submission Type Special
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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K052186.
ADULT CEREBRAL OXIMETER, MODEL 2040
K051257 · Cas Medical Systems, Inc. · Dec 2005
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K053269 · Masimo Corporation · Dec 2005
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
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WRISTOX MODEL 3100 PULSE OXIMETER
K052829 · Nonin Medical, Inc. · Nov 2005
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · Ge Healthcare · Oct 2005
OXIMAX NPB-40 HANDHELD PULSE OXIMETER
K051352 · Nellcor Puritan Bennett, Inc. · Aug 2005