510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K803105Substantially Equivalent

Sarns Infant Arterial Bubble Sensor

3M Health Care, Sarns, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803105 is the FDA 510(k) clearance record for SARNS INFANT ARTERIAL BUBBLE SENSOR, a class II device, cleared for 3M Health Care, Sarns on under FDA product code KPL (Colonic Irrigation System). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show no recalls naming K803105.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
3M Health Care, Sarns 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

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