510(k) · Cleared

Cleared

Savina 300 Savina 300, Country Variants

K121886510(k) TraditionalCleared Aug 8, 2014771-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

Draeger Medical GmbH · CBK Ventilator, Continuous, Facility Use

Cleared on Aug 8, 2014 as substantially equivalent to K003068 (Drager Medizintechnik GmbH, 2001) and 2 other predicates after a 771-day review. Its family tree reaches back 8 generations to 1997. 4 of the 21 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Aug 8, 2014
Review: 771 days
Class: Class II
Product code: CBK
Recalls: None
Predicates: 3

Its longest line of descent runs back 8 generations to K962603 (1997). 19 ancestors in all, the oldest K943531 (1995). 1 later device descends from it, 1 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
6 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
5 generations backK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
4 generations backK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
3 generations backK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
2 generations backK082600 Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic…Draeger Medical B.V. · 2008 · Recalled (Class I)
1 generation backK103625 Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · Recalled (Class I)
This deviceK121886 Savina 300 Savina 300, Country VariantsDraeger Medical GmbH · 2014
Descendant · cites it directly · 0 of its ownK180779 Savina 300Dragerwerk AG & CO Kgaa · 2019

Class I recalls in this family

K103625 Oxylog 3000 Plus Workstation, Oxylog 3000 Plus…direct predicate · 2011
K093633 Infinity Acute Care System Workstation Critical…direct predicate · 2010
K082600 Oxylog 2000 Plus System (Model 5705080), Oxylog…2 generations back · 2008
K062267 Oxylog 30002 generations back · 2006

Most influential descendants

Showing 1 of 1 · See all

K180779Savina 300Dragerwerk AG & CO Kgaa · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−7	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−6	K990966	Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable…	Masimo Corp.	1999	—
−5	K021981	Ivent 201 Portable Ventilator	Versamed, Ltd.	2003	—
−4	K042468	Ivent 201 Portable Ventilator	Versamed Medical Systems, Inc.	2004	—
−3	K062267	Oxylog 3000	Drager Medical B.V.	2006	Class I
−2	K082600	Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model…	Draeger Medical B.V.	2008	Class I
−1	K103625	Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device	Draeger Medical Systems, Inc.	2011	Class I
0 (this device)	K121886	Savina 300 Savina 300, Country Variants	Draeger Medical GmbH	2014	—
+1	K180779	Savina 300	Dragerwerk AG & CO Kgaa	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1996	1	0
1998	1	0
1999	2	0
2000	1	0
2001	2	0
2004	1	0
2010	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K121886, 1997–2019Source: 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 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? (3)

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
*	K003068	Savina Summary page 8 …ly marketed device) \| (legally marketed device) Manufacturer Dréger Medical GmbH Drager Medical GmbH Drager Medical GmbH Drager Medical GmbH US FDA 510(k) number K121886 K003068 (Savina) K093633 K103625 K023289 (NIV Option) K040642 (LPO Option) FDA Regulation number To be assigned 868.5895 868.5895 868.589…	Drager Medizintechnik GmbH	2001	—
*	K093633	Infinity Acute Care System Workstation Critical Care Summary page 8 …e) \| (legally marketed device) Manufacturer Dréger Medical GmbH Drager Medical GmbH Drager Medical GmbH Drager Medical GmbH US FDA 510(k) number K121886 K003068 (Savina) K093633 K103625 K023289 (NIV Option) K040642 (LPO Option) FDA Regulation number To be assigned 868.5895 868.5895 868.5895 FDA Product cod…	Draegerwerk AG & CO Kgaa	2010	Class I
*	K103625	Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device Summary page 8 …gally marketed device) Manufacturer Dréger Medical GmbH Drager Medical GmbH Drager Medical GmbH Drager Medical GmbH US FDA 510(k) number K121886 K003068 (Savina) K093633 K103625 K023289 (NIV Option) K040642 (LPO Option) FDA Regulation number To be assigned 868.5895 868.5895 868.5895 FDA Product code CBK CB…	Draeger Medical Systems, Inc.	2011	Class I

Also cleared against K003068: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K180779	Savina 300	Dragerwerk AG & CO Kgaa	2019	0

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.

K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
5 of the 19 ancestors have a recall of any class; 4 have a Class I recall.
Of its descendants, K180779 (Dragerwerk AG & CO Kgaa, 2019) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K003068.

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. 2014, 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?

Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (11Ibs) bodyweight.

Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

- In intensive care wards, recovery rooms and generally for hospital use

- During the transport of ventilated patients within the hospital

- During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)

- During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K121886 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121886: Savina 300 Savina 300, Country Variants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121886

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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