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
K841913Substantially Equivalent

Temptrend Peds Axillary Temp. Indicator

Biosynergy, Inc., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841913 is the FDA 510(k) clearance record for TEMPTREND PEDS AXILLARY TEMP. INDICATOR, a class II device, cleared for Biosynergy, Inc. on under FDA product code KPD (Strip, Temperature, Forehead, Liquid Crystal). FDA records list 2 510(k) clearances for Biosynergy, Inc., from to . As of , FDA records show no recalls naming K841913.

Clearance record

Decision date
Received
(177 days to decision)
Product code
KPD Strip, Temperature, Forehead, Liquid Crystal
Regulation
21 CFR 880.2200
Device class
Class II
Review panel
General Hospital
Applicant
Biosynergy, Inc. 724, Arlington Heights IL
Third party review
No

Clearances, product code KPD

Trailing 12 months

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

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