510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923225Substantially Equivalent

Lorrex Health Products - Clinical Mercury Thermome

Lorrex Health Products, Secaucus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923225 is the FDA 510(k) clearance record for LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME, a class II device, cleared for Lorrex Health Products on under FDA product code FLK (Thermometer, Clinical Mercury). FDA records list 16 510(k) clearances for Lorrex Health Products, from to . As of , FDA records show no recalls naming K923225.

Clearance record

Decision date
Received
(342 days to decision)
Product code
FLK Thermometer, Clinical Mercury
Regulation
21 CFR 880.2920
Device class
Class II
Review panel
General Hospital
Applicant
Lorrex Health Products 301 Penhorn Ave., Secaucus NJ
510(k) summary
Statement
Third party review
No

Clearances, product code FLK

Trailing 12 months

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

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