Cleared Traditional

K041127 - MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

K041127 is an FDA 510(k) clearance for MODIFICATION TO: REPROCESSED OXIMAX PUL..., manufactured by Sterilmed, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K041127

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.

NLF Device Classification - Class 2, Special Controls

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 21
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
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
K041867 · Hygia Health Services, Inc. · Sep 2004
REPROCESSED PULSE OXIMETER SENSORS
K012677 · Sterilmed, Inc. · Mar 2003
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344 · Vanguard Medical Concepts, Inc. · Oct 2002