Cleared Traditional

DATEX-OHMEDA OXY-AFR SENSOR (K042891) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042891 · Datex-Ohmeda · Anesthesiology device
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Jun 2005
Decision
253d
Days
Class 2
Risk

K042891 is an FDA 510(k) clearance for the DATEX-OHMEDA OXY-AFR SENSOR. Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 253 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 Datex-Ohmeda devices

Submission Details

510(k) Number K042891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date June 29, 2005
Days to Decision 253 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
113d slower than avg
Panel avg: 140d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NLF Oximeter, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
Definition Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NLF Oximeter, Reprocessed

Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K042891.
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
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Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
K191018 · Surgical Instrument Service and Savings, Inc. · Jul 2019