510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Memory Module, E-Mem

K052756510(k) SpecialCleared Nov 1, 200532-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Nov 1, 2005 as substantially equivalent to K945234 (Datex Division Instrumentarium Corp., 1995) after a 32-day review. Its family tree reaches back 1 generation to 1995.

Decided: Nov 1, 2005
Review: 32 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945234 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK945234 AS/3 Memory Module, M0MEMDatex Division Instrumentarium Corp. · 1995
This deviceK052756 Datex-Ohmeda S/5 Memory Module, E-MemGE Healthcare · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945234	AS/3 Memory Module, M0MEM	Datex Division Instrumentarium Corp.	1995	—
0 (this device)	K052756	Datex-Ohmeda S/5 Memory Module, E-Mem	GE Healthcare	2005	—

FIG. 1 — Lineage of K052756, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K945234	AS/3 Memory Module, M0MEM Summary page 1 …e Datex-Ohmeda S/5TM" Memory Module, E-MEM is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-MEM Module (K945234). Page 2 of 3 DE…	Datex Division Instrumentarium Corp.	1995	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

What is it indicated for?

The Datex-Ohmeda S/5 TM E-MEM module is indicated for storing patient related physiological data, discrete record keeping events, and menu configurations in removable flash memory cards. The device is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052756: Datex-Ohmeda S/5 Memory Module, E-Mem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052756

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026