Manual Ventilation Accessory

K854036510(k) TraditionalCleared Oct 23, 198557-day review

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

Cleared on Oct 23, 1985 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.

Decided: Oct 23, 1985
Review: 57 days
Recalls: None
Predicates: 0

7 later devices descend from it, 1 citing it directly. 3 of the 8 devices in this family, counting this one, have a Class I recall.

This deviceK854036 Manual Ventilation AccessorySiemens Elema AB · 1985
Descendant · cites it directly · 6 of its ownK973971 Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999
Descendant · 2 generations on · 5 of its ownK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004 · Recalled
Descendant · 3 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 · 4 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 · 5 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999high 1 (1999) · low 0 (2000)2026

Class I recalls in this family

K112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet…4 generations on · 2012
K133958 Flow-I Anesthesia System C20, C30 & C405 generations on · 2014
K191027 Flow-i Anesthesia System, Flow-c Anesthesia…7 generations on · 2020

Most influential descendants

Showing 5 of 7 · See all

K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999 · cites it directly6descendants
K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc. · 2004 · 2 generations on5descendants
K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · 3 generations on4descendants
K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 4 generations on3descendants
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K854036	Manual Ventilation Accessory	Siemens Elema AB	1985	—
+1	K973971	Kion Anesthesia System	Siemens Medical Solutions USA, Inc.	1999	—
+2	K024213	Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64…	Siemens Medical Solutions USA, Inc.	2004	1
+3	K102182	Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30	Maquet Critical Care AB	2011	—
+4	K112114	Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40	Maquet Critical Care AB	2012	Class I
+5	K133958	Flow-I Anesthesia System C20, C30 & C40	Maquet Critical Care AB	2014	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0
2011	1	0
2012	1	1
2014	1	1
2017	1	0
2020	1	1

FIG. 1 — Lineage of K854036, 1985–2020Source: 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (7)

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

Number	Device	Applicant	Decided	Descendants
K973971	Kion Anesthesia System	Siemens Medical Solutions USA, Inc.	1999	6

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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

Of its descendants, K973971 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 6 descendants of its own.

https://510kreport.com/device/K854036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854036: Manual Ventilation Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854036

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Record history

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