510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834152Substantially Equivalent

Ethylene Oxide Detector Gld-1-07

Calnor of el Paseo, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834152 is the FDA 510(k) clearance record for ETHYLENE OXIDE DETECTOR GLD-1-07, a class II device, cleared for Calnor of EL Paseo, Inc. on under FDA product code FLE (Sterilizer, Steam). FDA records list 6 510(k) clearances for Calnor of EL Paseo, Inc., from to . As of , FDA records show no recalls naming K834152.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Calnor of EL Paseo, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260