510(k) · Cleared

Cleared

Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30

K102182510(k) AbbreviatedCleared May 9, 2011279-day reviewClass II21 CFR 868.5160

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

Maquet Critical Care AB · BSZ Gas-Machine, Anesthesia

Cleared on May 9, 2011 as substantially equivalent to K024213 (Siemens Medical Solutions USA, Inc., 2004) and 1 other predicate after a 279-day review. Its family tree reaches back 8 generations to 1994. 4 of the 39 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.

Decided: May 9, 2011
Review: 279 days
Class: Class II
Product code: BSZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K930017 (1994). 34 ancestors in all, the oldest K811102 (1981). 4 later devices descend from it, 1 citing it directly. 4 of the 39 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
7 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
6 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
5 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
4 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
3 generations backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
2 generations backK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
1 generation backK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
This deviceK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
Descendant · cites it directly · 3 of its ownK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
Descendant · 2 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
Descendant · 3 generations on · 1 of its ownK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017
Descendant · 4 generations on · 0 of its ownK191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e…Maquet Critical Care AB · 2020 · Recalled (Class I)

Class I recalls in this family

K023366 Datex-Ohmeda 7900 Ventilator Enhancements5 generations back · 2003
K112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet…cites it directly · 2012
K133958 Flow-I Anesthesia System C20, C30 & C402 generations on · 2014
K191027 Flow-i Anesthesia System, Flow-c Anesthesia…4 generations on · 2020

Most influential descendants

Showing 4 of 4 · See all

K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · cites it directly3descendants
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 2 generations on2descendants
K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB · 2017 · 3 generations on1descendant
K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K930017	PB 7200 Series Ventilatory System W/Keyboard	Puritan Bennett Corp.	1994	—
−7	K023366	Datex-Ohmeda 7900 Ventilator Enhancements	Datex-Ohmeda, Inc.	2003	Class I
−6	K040743	Modification to Datex-Ohmeda S/5 Avance Anesthesia System	Datex-Ohmeda, Inc.	2004	—
−5	K042154	GE Datex-Ohmeda Aisys Carestation	Datex-Ohmeda, Inc.	2004	3
−4	K061609	GE Datex-Ohmeda Aisys	Datex-Ohmeda, Inc.	2006	1
−3	K071142	GE Datex-Ohmeda Avance Anesthesia System	Datex-Ohmeda	2007	—
−2	K081844	GE Datex-Ohmeda Avance	Datex-Ohmeda, Inc.	2008	4
−1	K090233	GE Datex-Ohmeda Aisys	Datex-Ohmeda, Inc.	2009	2
0 (this device)	K102182	Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30	Maquet Critical Care AB	2011	—
+1	K112114	Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40	Maquet Critical Care AB	2012	Class I
+2	K133958	Flow-I Anesthesia System C20, C30 & C40	Maquet Critical Care AB	2014	Class I
+3	K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia…	Maquet Critical Care AB	2017	—
+4	K191027	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System	Maquet Critical Care AB	2020	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	2	0
1985	2	0
1986	1	0
1987	1	0
1989	2	0
1991	1	0
1993	1	0
1995	2	0
1996	3	0
1997	1	0
1998	2	0
1999	1	0
2000	2	0
2002	1	0
2004	2	0
2008	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K102182, 1994–2020Source: 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.

4 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 BSZ device

#1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 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? (2)

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
*	K024213	Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910… Summary page 4 …stem Comparison of Technological Characteristics to Predicate Devices Comparison of Intended Use The intended use for the subject device and the predicate devices KION K0242 13 and Aisys K090233 is in all essentials the same. The devices are all intended for delivery of inhalation anesthesia for the patie…	Siemens Medical Solutions USA, Inc.	2004	1
*	K090233	GE Datex-Ohmeda Aisys Summary page 1 …= 0()# Maquet, KION Anesthesia Workstation K0413 GE Datex-Obmeda, Aisys Anesthesia System K090233 Maue,ERO ietilator System K073179…	Datex-Ohmeda, Inc.	2009	2
†	K073179	Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585	Maquet Critical Care AB	2008	—

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K112114	Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 Class I	Maquet Critical Care AB	2012	3

Has anything in its family been recalled? (4 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.

K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 2 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 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
12 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K112114 (Maquet Critical Care AB, 2012) has gone furthest, with 3 descendants of its own.

How does its category compare?

All BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · BSZ

1in 2025

2007high 8 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSZ

145in 2017

2007high 235 (2014) · low 34 (2009)2026

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

Recalls per year · BSZ

5in 2025

2007high 14 (2010) · low 0 (2014)2026

Class I (38 since 2007) Class II/III not classified

Adverse event reports per year · BSZ

9,198in 2025

2007high 9,198 (2025) · low 85 (2009)2025

MAUDE reports naming product code BSZ, 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	3	175	1	132
2008	8	99	8	104
2009	3	34	3	85
2010	1	—	14	97
2011	6	218	1	87
2012	5	134	7 (6)	89
2013	5	125	5 (5)	308
2014	4	235	0	279
2015	4	134	7 (2)	572
2016	1	—	1	2,135
2017	3	145	5 (1)	2,355
2018	2	—	3	2,589
2019	0	—	5 (2)	1,957
2020	1	—	7	2,687
2021	1	—	2 (1)	3,123
2022	0	—	4 (3)	4,352
2023	2	—	6	5,595
2024	0	—	13 (13)	6,067
2025	1	—	5 (3)	9,198
2026	2	—	7 (2)	—

What is it indicated for?

The indication for FLOW-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation anesthesia administration.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102182: Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102182

Report an extraction error

Are you the manufacturer?

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