Cleared Traditional

K081927 - RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO

K081927 is an FDA 510(k) clearance for RENU MEDICAL OXIMETRY SENSOR, manufactured by Renu Medical, Inc.. The device is a Class 2 Anesthesiology device with product code NLF cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K081927 · Renu Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
214d
Days
Class 2
Risk

K081927 is an FDA 510(k) clearance for the RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO. Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 214 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 Renu Medical, Inc. devices

FDA 510(k) Submission Details - K081927

510(k) Number K081927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date February 06, 2009
Days to Decision 214 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
74d slower than avg
Panel avg: 140d · This submission: 214d
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 26
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K081927.
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
K101280 · Midwest Reprocessing Center, LLC · Oct 2010
REPROCESSED PULSE OXIMETER SENSORS
K092368 · Sterilmed, Inc. · Nov 2009
LNCS OXIMETRY SENSORS
K083719 · Masimo Corporation · Jul 2009
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238 · Ascent Healthcare Solutions · Jul 2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
K080424 · Hygia Health Services, Inc. · May 2008
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
K072194 · Renu Medical, Inc. · Nov 2007