510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811631Substantially Equivalent

Thermometer (Made in China)

Robert I. Chien & Assoc., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811631 is the FDA 510(k) clearance record for THERMOMETER (MADE IN CHINA), a class II device, cleared for Robert I. Chien & Assoc., Inc. on under FDA product code FLK (Thermometer, Clinical Mercury). FDA records list 6 510(k) clearances for Robert I. Chien & Assoc., Inc., from to . As of , FDA records show no recalls naming K811631.

Clearance record

Decision date
Received
(41 days to decision)
Product code
FLK Thermometer, Clinical Mercury
Regulation
21 CFR 880.2920
Device class
Class II
Review panel
General Hospital
Applicant
Robert I. Chien & Assoc., Inc. 803 N. Front St. Suite 3, Mchenry IL
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