510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243965Substantially Equivalent

Origin™

Nerv Technology Inc. (D.B.A.) Fluidai Medical, Kitchener, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243965 is the FDA 510(k) clearance record for Origin™, a class II device, cleared for Nerv Technology Inc. (D.B.A.) Fluidai Medical on under FDA product code SFO (Electrode Measurement, Drain Effluent Ph). FDA's definition for product code SFO reads: "Measurement of drain effluent pH". FDA records list one 510(k) clearance for Nerv Technology Inc. (D.B.A.) Fluidai Medical. As of , FDA records show no recalls naming K243965.

Clearance record

Decision date
Received
(241 days to decision)
Product code
SFO Electrode Measurement, Drain Effluent Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nerv Technology Inc. (D.B.A.) Fluidai Medical 809 Wellington St. N., Kitchener, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFO

Trailing 12 months

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

FDA records show no clearances under product code SFO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFO, 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