Cleared Traditional

K012715 - HYGIA HEALTH SERVICES REPROCESSED NELLC...

K012715 is an FDA 510(k) clearance for HYGIA HEALTH SERVICES REPROCESSED NELLC..., 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 717-day FDA review.

K012715 · Hygia Health Services, Inc. · Anesthesiology device
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Aug 2003
Decision
717d
Days
Class 2
Risk

K012715 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II. 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 August 1, 2003 after a review of 717 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hygia Health Services, Inc. devices

FDA 510(k) Submission Details - K012715

510(k) Number K012715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date August 01, 2003
Days to Decision 717 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
577d slower than avg
Panel avg: 140d · This submission: 717d
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 K012715.
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
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
K041127 · Sterilmed, Inc. · Sep 2004
REPROCESSED PULSE OXIMETER SENSORS
K012677 · Sterilmed, Inc. · Mar 2003
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344 · Vanguard Medical Concepts, Inc. · Oct 2002