510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100129Substantially Equivalent

Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X

Ambu A/S, Glen Burnie MD / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100129 is the FDA 510(k) clearance record for AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X, a class II device, cleared for Ambu A/S on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 13 510(k) clearances for Ambu A/S, from to . As of , FDA records show no recalls naming K100129.

Clearance record

Decision date
Received
(143 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Ambu A/S 6740 Baymeadow Dr., Glen Burnie MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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