510(k) · Cleared

Cleared

Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option

K062793510(k) TraditionalCleared Feb 7, 2007142-day reviewClass II21 CFR 868.5895

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 · CBK Ventilator, Continuous, Facility Use

Cleared on Feb 7, 2007 as substantially equivalent to K061090 (Hamilton Medical AG, 2006) and 12 other predicates after a 142-day review. Its family tree reaches back 8 generations to 1991. 5 of the 50 devices in its family, counting itself, have a Class I recall.

Decided: Feb 7, 2007
Review: 142 days
Class: Class II
Product code: CBK
Recalls: None
Predicates: 13

Its longest line of descent runs back 8 generations to K902859 (1991). 49 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 5 of the 50 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
7 generations backK961687 EVITA 4Drager, Inc. · 1996
6 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
5 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
4 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
3 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
2 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
1 generation backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
This deviceK062793 Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB · 2007

Class I recalls in this family

K053388 Model 840 Ventilator with Proportional Assist…direct predicate · 2006
K013642 AVEAdirect predicate · 2002
K970460 Nellcor Puritan Bennett, 840 Ventilator System…2 generations back · 1998
K001646 Puritan-Bennett 840 Ventilator System with…3 generations back · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K902859	Servo Ventilator 300	Siemens Life Support Systems	1991	3
−7	K961687	EVITA 4	Drager, Inc.	1996	—
−6	K970460	Nellcor Puritan Bennett, 840 Ventilator System (Model 840)	Puritan Bennett Corp.	1998	Class I
−5	K984535	Puritan-Bennett 840 Ventilatory System with Bilevel Option	Puritan Bennett Corp.	1998	Class I
−4	K022679	Raphael	Hamilton Medical AG	2003	3
−3	K040574	Galileo Gold	Hamilton Medical, Inc.	2004	—
−2	K051263	Evitaxl with Option Smartcare	Drager Medical AG & Co. Kgaa	2005	1
−1	K053388	Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option	Puritan Bennett Corp.	2006	Class I
0 (this device)	K062793	Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option	Maquet Critical Care AB	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	3	0
1991	3	0
1992	3	0
1993	1	0
1994	4	0
1995	2	0
1996	2	0
1997	3	0
1998	4	0
1999	4	0
2000	3	1
2001	4	0
2002	3	1
2004	1	0
2006	1	0

FIG. 1 — Lineage of K062793, 1991–2007Source: 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.

5 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 CBK device

#1 K252663 Inbentus Versatilescore 16.0 · 17 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? (13)

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
*	K061090	Galileo Gold Asv Summary page 1 …tion Legally marketed devices to which equivalence is being claimed 510(k) Galileo Gold Hamilton w ASV option K061090 Puritan Bennett w PAV± option K053388 Drager EVITA XL w Smart Care…	Hamilton Medical AG	2006	—
*	K053388	Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option Summary page 1 …(k) Galileo Gold Hamilton w ASV option K061090 Puritan Bennett w PAV± option K053388 Drager EVITA XL w Smart Care K051263 Servo-i ventilator family…	Puritan Bennett Corp.	2006	Class I
*	K051263	Evitaxl with Option Smartcare Summary page 1 …090 Puritan Bennett w PAV± option K053388 Drager EVITA XL w Smart Care K051263 Servo-i ventilator family K040221 Avea with Bicore option…	Drager Medical AG & Co. Kgaa	2005	1
*	K040221	Servo-I Ventilator System, Model 64 87 800 E407E Summary page 1 …388 Drager EVITA XL w Smart Care K051263 Servo-i ventilator family K040221 Avea with Bicore option K013642 M A Q UET Object/Subject…	Maquet Critical Care AB	2004	1
*	K013642	AVEA Summary page 1 …263 Servo-i ventilator family K040221 Avea with Bicore option K013642 M A Q UET Object/Subject Document Type 12…	Bird Products Corp.	2002	Class I
*	K942852	Respitrace PT Summary page 2 …ventilator with NAVA option EVU-120018 - 00 Respitrace K942852 Bicore K935788 Sechrist Savi…	Non-Invasive Monitoring Systems, Inc.	1996	—
*	K935788	Bicore Smartcath Intratracheal Catheter Summary page 2 …- 00 Respitrace K942852 Bicore K935788 Sechrist Savi K920121 Infant Star…	Bicore Monitoring Systems	1995	—
*	K920121	Sechrist IV-100B Savi System Summary page 2 …K942852 Bicore K935788 Sechrist Savi K920121 Infant Star K923704 Arzco esophagus electrodes (bi-polar)…	Sechrist	1993	1
*	K923704	Infant Star Series 500 Summary page 2 …K935788 Sechrist Savi K920121 Infant Star K923704 Arzco esophagus electrodes (bi-polar) K903136 Arzco esophagus electrodes (8 electrodes)…	Infrasonics Corp.	1992	—
*	K903136	Arzo Tapcath Esophageal Recording Catheter Summary page 2 …K920121 Infant Star K923704 Arzco esophagus electrodes (bi-polar) K903136 Arzco esophagus electrodes (8 electrodes) K905831 Vygon Gastric Feeding tube - for function…	Arzco Medical Electronics, Inc.	1991	—
*	K905831	Arzco Octapolar Esophageal Cardiac Record Cath Summary page 2 …K923704 Arzco esophagus electrodes (bi-polar) K903136 Arzco esophagus electrodes (8 electrodes) K905831 Vygon Gastric Feeding tube - for function K925854 Utah medical (Gesco) Umbilical catheter - f…	Arzco Medical Electronics, Inc.	1991	—
*	K925854	Vygon - Enteral Feeding Tube - Polyurethane Summary page 2 …K903136 Arzco esophagus electrodes (8 electrodes) K905831 Vygon Gastric Feeding tube - for function K925854 Utah medical (Gesco) Umbilical catheter - for material K940870 Device Description Summary of technological…	Vygon Corp.	1994	—
*	K940870	Umbili-Cath Summary page 2 …K905831 Vygon Gastric Feeding tube - for function K925854 Utah medical (Gesco) Umbilical catheter - for material K940870 Device Description Summary of technological characteristics of modified Device and Predicate Device: The predicate device Servo-…	Gesco Intl., Inc.	1994	—

Also cleared against K061090: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (5 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.

K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K013642AVEABird Products Corp. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
17 of the 49 ancestors have a recall of any class; 5 have a Class I recall.
3 other devices also cite its predicate K061090.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CBK

4in 2025

2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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	11	142	17	1,531
2008	18	115	23	1,933
2009	12	122	8	1,766
2010	14	150	9	1,799
2011	13	192	12	1,877
2012	17	207	2 (1)	5,509
2013	5	277	5 (2)	7,921
2014	5	439	5 (4)	7,600
2015	7	266	6 (4)	11,876
2016	4	323	4 (1)	16,056
2017	6	280	1	14,451
2018	4	183	3 (3)	9,849
2019	8	435	14 (13)	9,100
2020	5	176	4	11,096
2021	6	267	21 (19)	13,322
2022	0	—	8 (4)	15,974
2023	5	309	4 (3)	24,928
2024	9	203	14 (14)	20,336
2025	4	163	0	13,991
2026	3	235	15 (13)	—

What is it indicated for?

The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchrony between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062793 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062793: Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062793

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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