510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K913793Substantially Equivalent

Simpex Inc. Oral and Rectal Thermometers

Simpex, Inc., Jenkintown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913793 is the FDA 510(k) clearance record for SIMPEX INC. ORAL AND RECTAL THERMOMETERS, a class II device, cleared for Simpex, Inc. on under FDA product code FLK (Thermometer, Clinical Mercury). FDA records list 5 510(k) clearances for Simpex, Inc., from to . As of , FDA records show no recalls naming K913793.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FLK Thermometer, Clinical Mercury
Regulation
21 CFR 880.2920
Device class
Class II
Review panel
General Hospital
Applicant
Simpex, Inc. 801 Old York Rd., Jenkintown PA
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