510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932991Substantially Equivalent

Guardian and Andino Models

Coltemp, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932991 is the FDA 510(k) clearance record for GUARDIAN AND ANDINO MODELS, a class II device, cleared for Coltemp, Inc. on under FDA product code FLK (Thermometer, Clinical Mercury). FDA records list one 510(k) clearance for Coltemp, Inc. As of , FDA records show no recalls naming K932991.

Clearance record

Decision date
Received
(224 days to decision)
Product code
FLK Thermometer, Clinical Mercury
Regulation
21 CFR 880.2920
Device class
Class II
Review panel
General Hospital
Applicant
Coltemp, Inc. 8900 SW 107 Ave. Suite 311, Miami FL
510(k) summary
Summary
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