Cleared Traditional

K041127 - MODIFICATION TO: REPROCESSED OXIMAX PUL...

K041127 is the FDA 510(k) clearance for MODIFICATION TO: REPROCESSED OXIMAX PUL... by Sterilmed, Inc.. It is a Class 2 Anesthesiology device (product code NLF) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K041127 · Sterilmed, Inc. · Anesthesiology device
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Sep 2004
Decision
146d
Days
Class 2
Risk

K041127 is an FDA 510(k) clearance for the MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS. Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 23, 2004 after a review of 146 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. 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K041127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date September 23, 2004
Days to Decision 146 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
6d slower than avg
Panel avg: 140d · This submission: 146d
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

All 14
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K041127.
DATEX-OHMEDA OXY-AFR SENSOR
K042891 · Datex-Ohmeda · Jun 2005
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K042316 · Vanguard Medical Concepts, Inc. · Jan 2005
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
K033973 · Nellcor Puritan Bennett, Inc. · Dec 2004
REPROCESSED PULSE OXIMETER SENSORS
K012677 · Sterilmed, Inc. · Mar 2003
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344 · Vanguard Medical Concepts, Inc. · Oct 2002