510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200042Unknown

BrainTemp Neonate System (BTNeo System)

Brain Temp, Inc., Bryn Mawr PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200042 is the FDA 510(k) clearance record for BrainTemp Neonate System (BTNeo System), a class II device, cleared for Brain Temp, Inc. on under FDA product code QSL (Brain Temperature Measurement System). FDA's definition for product code QSL reads: "A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature". FDA records list one 510(k) clearance for Brain Temp, Inc. As of , FDA records show no recalls naming DEN200042.

Clearance record

Decision date
Received
(644 days to decision)
Product code
QSL Brain Temperature Measurement System
Regulation
21 CFR 882.1565
Device class
Class II
Review panel
Neurology
Applicant
Brain Temp, Inc. P.O. Box 823, Bryn Mawr PA
Third party review
No

Clearances, product code QSL

Trailing 12 months

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

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