510(k) · Cleared

Cleared

Kion Anaesthesia System, Model 65 03 879 E392E

K010923510(k) AbbreviatedCleared Jan 23, 2002302-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

Siemens Elema AB · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jan 23, 2002 after a 302-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 7 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided: Jan 23, 2002
Review: 302 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

6 later devices descend from it, 1 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.

This deviceK010923 Kion Anaesthesia System, Model 65 03 879 E392ESiemens Elema AB · 2002
Descendant · cites it directly · 5 of its ownK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004 · Recalled
Descendant · 2 generations on · 4 of its ownK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
Descendant · 3 generations on · 3 of its ownK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
Descendant · 4 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
Descendant · 5 generations on · 1 of its ownK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2005)2026

Class I recalls in this family

K112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet…3 generations on · 2012
K133958 Flow-I Anesthesia System C20, C30 & C404 generations on · 2014
K191027 Flow-i Anesthesia System, Flow-c Anesthesia…6 generations on · 2020

Most influential descendants

Showing 5 of 6 · See all

K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc. · 2004 · cites it directly5descendants
K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · 2 generations on4descendants
K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 3 generations on3descendants
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 4 generations on2descendants
K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB · 2017 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010923	Kion Anaesthesia System, Model 65 03 879 E392E	Siemens Elema AB	2002	—
+1	K024213	Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64…	Siemens Medical Solutions USA, Inc.	2004	1
+2	K102182	Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30	Maquet Critical Care AB	2011	—
+3	K112114	Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40	Maquet Critical Care AB	2012	Class I
+4	K133958	Flow-I Anesthesia System C20, C30 & C40	Maquet Critical Care AB	2014	Class I
+5	K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia…	Maquet Critical Care AB	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2011	1	0
2012	1	1
2014	1	1
2017	1	0
2020	1	1

FIG. 1 — Lineage of K010923, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

3 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K024213	Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…	Siemens Medical Solutions USA, Inc.	2004	5

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

Of its descendants, K024213 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 5 descendants of its own.

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	—

https://510kreport.com/device/K010923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010923: Kion Anaesthesia System, Model 65 03 879 E392E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010923

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026