510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924487Substantially Equivalent

Red Dot 2515 Cardiac Sensor System

3M Company, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924487 is the FDA 510(k) clearance record for RED DOT 2515 CARDIAC SENSOR SYSTEM, a class I device, cleared for 3M Health Care, Ltd. on under FDA product code BRX (Stool, Anesthesia). FDA records list 58 510(k) clearances for 3M COMPANY, from to . As of , FDA records show no recalls naming K924487.

Clearance record

Decision date
Received
(111 days to decision)
Product code
BRX Stool, Anesthesia
Regulation
21 CFR 868.6700
Device class
Class I
Review panel
Anesthesiology
Applicant
3M Health Care, Ltd. 3m Center, Bldg. 275-3e-08, St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code BRX

Trailing 12 months

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

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