Cleared Traditional

K080424 - HYGIA HEALTH SERVICES REPROCESSED LNCS ...

K080424 is an FDA 510(k) clearance for HYGIA HEALTH SERVICES REPROCESSED LNCS ..., manufactured by Hygia Health Services, Inc.. The device is a Class 2 Anesthesiology device with product code NLF cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K080424 · Hygia Health Services, Inc. · Anesthesiology device
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May 2008
Decision
103d
Days
Class 2
Risk

K080424 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HH.... Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Hygia Health Services, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 28, 2008 after a review of 103 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 Hygia Health Services, Inc. devices

FDA 510(k) Submission Details - K080424

510(k) Number K080424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2008
Decision Date May 28, 2008
Days to Decision 103 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
37d faster than avg
Panel avg: 140d · This submission: 103d
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 15
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K080424.
REPROCESSED PULSE OXIMETER SENSORS
K102560 · Sterilmed, Inc. · Feb 2011
REPROCESSED PULSE OXIMETER SENSORS
K092368 · Sterilmed, Inc. · Nov 2009
LNCS OXIMETRY SENSORS
K083719 · Masimo Corporation · Jul 2009
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