Cleared Special

K052755 - DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SAT...

K052755 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SAT..., manufactured by Ge Healthcare. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 13-day FDA review.

K052755 · Ge Healthcare · Anesthesiology device
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Oct 2005
Decision
13d
Days
Class 2
Risk

K052755 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on October 13, 2005 after a review of 13 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.

View all Ge Healthcare devices

FDA 510(k) Submission Details - K052755

510(k) Number K052755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date October 13, 2005
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
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 K052755.
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
K052377 · Philips Medizin Systeme Boeblingen GmbH · Nov 2005
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
K052186 · Nellcor Puritan Bennett, Inc. · Nov 2005
WRISTOX MODEL 3100 PULSE OXIMETER
K052829 · Nonin Medical, Inc. · Nov 2005
OXIMAX NPB-40 HANDHELD PULSE OXIMETER
K051352 · Nellcor Puritan Bennett, Inc. · Aug 2005
LNOP BLUE OXIMETRY SENSOR
K051439 · Masimo Corporation · Jul 2005
MODIFICATION TO LNCS OXIMETRY SENSORS
K051212 · Masimo Corporation · Jul 2005