Cleared Traditional

K050014 - HEMONIR TM

K050014 is an FDA 510(k) clearance for HEMONIR TM, manufactured by Nir Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GLY cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K050014 · Nir Diagnostics, Inc. · Hematology device
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May 2005
Decision
122d
Days
Class 2
Risk

K050014 is an FDA 510(k) clearance for the HEMONIR TM. Classified as Oximeter To Measure Hemoglobin (product code GLY), Class II - Special Controls.

Submitted by Nir Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nir Diagnostics, Inc. devices

FDA 510(k) Submission Details - K050014

510(k) Number K050014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2005
Decision Date May 05, 2005
Days to Decision 122 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 113d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLY Device Classification - Class 2, Special Controls

Product Code GLY Oximeter To Measure Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 Hematology devices follow this clearance model.

Regulatory Peers - GLY Oximeter To Measure Hemoglobin

Devices cleared under the same product code (GLY) and FDA review panel - the closest regulatory comparables to K050014.
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
K993104 · Nova Biomedical Corp. · Dec 1999
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K955013 · Nova Biomedical Corp. · Apr 1996
MULTICHECK
K952725 · Radiometer America, Inc. · Feb 1996
AVL MODEL 912 CO-OXYLITE
K895466 · Avl Scientific Corp. · Nov 1989