510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042675Substantially Equivalent

Flexi-Stat Sp02 Ear Sensor

Elekon Industries U.S.A., Inc., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042675 is the FDA 510(k) clearance record for FLEXI-STAT SP02 EAR SENSOR, a class II device, cleared for Elekon Industries U.S.A., Inc. on under FDA product code DPZ (Oximeter, Ear). FDA records list 6 510(k) clearances for Elekon Industries U.S.A., Inc., from to . As of , FDA records show no recalls naming K042675.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DPZ Oximeter, Ear
Regulation
21 CFR 870.2710
Device class
Class II
Review panel
Cardiovascular
Applicant
Elekon Industries U.S.A., Inc. 2300 Mcdermott Rd., Plano TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPZ

Trailing 12 months

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

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