510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954351Substantially Equivalent

Series 50Xm

Hewlett-Packard Co., Wuerttemberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954351 is the FDA 510(k) clearance record for SERIES 50XM, a class II device, cleared for Hewlett-Packard GmbH on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 246 510(k) clearances for Hewlett-Packard GmbH, from to . As of , FDA records show no recalls naming K954351.

Clearance record

Decision date
Received
(172 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hewlett-Packard GmbH Schickard Strasse 4, Wuerttemberg, DE
510(k) summary
Summary
Third party review
No

Clearances, product code HGM

Trailing 12 months
2 clearances under product code HGM in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HGM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260