Cleared Traditional

K102560 - REPROCESSED PULSE OXIMETER SENSORS

K102560 is an FDA 510(k) clearance for REPROCESSED PULSE OXIMETER SENSORS, 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 164-day FDA review.

K102560 · Sterilmed, Inc. · Anesthesiology device
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Feb 2011
Decision
164d
Days
Class 2
Risk

K102560 is an FDA 510(k) clearance for the REPROCESSED 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 February 18, 2011 after a review of 164 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 Sterilmed, Inc. devices

FDA 510(k) Submission Details - K102560

510(k) Number K102560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date February 18, 2011
Days to Decision 164 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
24d slower than avg
Panel avg: 140d · This submission: 164d
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 K102560.
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
K191018 · Surgical Instrument Service and Savings, Inc. · Jul 2019
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
K111773 · Renu Medical, Inc. · Nov 2011
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
K110723 · Masimo Corporation · Jul 2011
REPROCESSED PULSE OXIMETER SENSORS
K092368 · Sterilmed, Inc. · Nov 2009
LNCS OXIMETRY SENSORS
K083719 · Masimo Corporation · Jul 2009
RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
K081927 · Renu Medical, Inc. · Feb 2009