510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012837Substantially Equivalent

Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories

GE Healthcare, Needham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012837 is the FDA 510(k) clearance record for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES, a class II device, cleared for Datex-Ohmeda on under FDA product code MLD (Monitor, St Segment With Alarm). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 2 recalls naming K012837.

Clearance record

Decision date
Received
(22 days to decision)
Product code
MLD Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex-Ohmeda 86 Pilgrim Rd., Needham MA
510(k) summary
Summary
Third party review
No

Clearances, product code MLD

Trailing 12 months

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

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