510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K050014Substantially Equivalent

Hemonir Tm

Nir Diagnostics, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050014 is the FDA 510(k) clearance record for HEMONIR TM, a class II device, cleared for Nir Diagnostics, Inc. on under FDA product code GLY (Oximeter To Measure Hemoglobin). FDA records list one 510(k) clearance for Nir Diagnostics, Inc. As of , FDA records show no recalls naming K050014.

Clearance record

Decision date
Received
(122 days to decision)
Product code
GLY Oximeter To Measure Hemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Nir Diagnostics, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GLY

Trailing 12 months

FDA records hold no clearances under product code GLY in the trailing twelve months.

FDA records show no clearances under product code GLY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GLY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260