510(k) · Cleared
ClearedMindray SV600 Ventilator, Mindray SV800 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Jun 16, 2023 as substantially equivalent to K083050 (Draeger Medical AG & Co. KG, 2008) and 1 other predicate after a 520-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jun 16, 2023
- Review
- 520 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902859 (1991). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
- 1 generation backK083050 Evite XLDraeger Medical AG & Co. KG · 2008
- This deviceK220107 Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243767 SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
| −1 | K083050 | Evite XL | Draeger Medical AG & Co. KG | 2008 | — |
| 0 (this device) | K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | — |
| +1 | K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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.
Planning a device in CBK? 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
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 | Decided |
|---|---|---|---|
| * | K083050 | Evite XLSummary page 4…ass: Class II Primary Product Code: CBK Panel: Anesthesiology 3. PREDICATE DEVICES Primary predicate: • K083050 - Evita XL Ventilator, Drager Medical AG & Co. KG Secondary predicate: • K202405 - BeneVision N Series Patient Monitor… | 2008 |
| * | K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22…Summary page 4…esthesiology 3. PREDICATE DEVICES Primary predicate: • K083050 - Evita XL Ventilator, Drager Medical AG & Co. KG Secondary predicate: • K202405 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, Be… | 2021 |
| † | K193228 | Hamilton-G5 | 2020 |
| † | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | 2019 |
| † | K103211 | Avea Ventilator | 2011 |
| † | K142679 | Carescape R860 | 2015 |
| † | K201957 | A8, A9 Anesthesia System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243767 | SV600, SV800 Ventilator | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K243767 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083050.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 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 SV600, SV800 Ventilators are intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220107 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220107: Mindray SV600 Ventilator, Mindray SV800 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220107
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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