510(k) · Cleared
ClearedServo-air Lite Ventilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Critical Care AB · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Jul 6, 2023 as substantially equivalent to K102985 (Respironics, Inc., 2011) after a 167-day review. Its family tree reaches back 6 generations to 1983. 3 of the 20 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 6, 2023
- Review
- 167 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K833786 (1983). 19 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 5 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 4 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 3 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 2 generations backK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
- 1 generation backK102985 V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK230173 Servo-air Lite Ventilator SystemMaquet Critical Care AB · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −5 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −4 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −3 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −2 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
| −1 | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software Options | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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.
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.
Top candidate predicates for a new MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software OptionsSummary page 5…Identification Respironics V60 K102985 Reference Device Ident… | 2011 |
| † | K192604 | Servo-air 4.0 Ventilator System | 2020 |
| † | K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator… | 2021 |
| † | K213521 | Nihon Kohden NKV-330 Ventilator System | 2022 |
| † | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 18 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 8 of the 19 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K102985.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | 0 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Servo-air Lite Ventilator System is an assist ventilator indicated for augmenting ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers non-invasive ventilation, invasive ventilation, and respiratory monitoring. Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above. Servo-air Lite Ventilator System is to…
Read the full statement (95 words)
Servo-air Lite Ventilator System is an assist ventilator indicated for augmenting ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers non-invasive ventilation, invasive ventilation, and respiratory monitoring.
Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.
Servo-air Lite Ventilator System is to be used only by healthcare professionals.
Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230173: Servo-air Lite Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230173
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