510(k) · Cleared
Recalled · Class I · 2023V60 Ventilator with PPV and Auto-Trak+ Software Options
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Apr 5, 2011 as substantially equivalent to K082660 (Respironics California, Inc., 2009) after a 180-day review. Its family tree reaches back 5 generations to 1983. 3 of the 23 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 9 times, including 8 Class I recalls.
- Decided
- Apr 5, 2011
- Review
- 180 days
- Class
- Class II
- Product code
- MNT
- Recalls
- 9 (8 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K833786 (1983). 18 ancestors in all, the oldest K811102 (1981). 4 later devices descend from it, 2 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 4 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 3 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 2 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 1 generation backK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
- This deviceK102985 V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK213521 Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252182 SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242931 HFT750UMekics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK230173 Servo-air Lite Ventilator SystemMaquet Critical Care AB · 2023
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022 · cites it directly2descendants
- K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026 · 2 generations on0descendants
- K242931HFT750UMekics Co., Ltd. · 2025 · 2 generations on0descendants
- K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −4 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −3 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −2 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −1 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
| 0 (this device) | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software Options | Respironics, Inc. | 2011 | — |
| +1 | K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022 | — |
| +2 | K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | — |
| +2 | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082660 | V60 Ventilator, Model V8000Summary page 1…Devices: Manufacturer Device Name 510(k) Number Respironics California, Inc. V60 Ventilator K082660 Intended Use of the Device: The V60 Ventilator with Proportional Pressure Ventilation (PPV) and Auto-Trak+ Software Options is a… | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2023 | Class I | Z-2631-2023 | Nonconforming Material/Component | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. |
| Feb 28, 2022 | Class I | Z-0908-2022 | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. |
| Feb 28, 2022 | Class I | Z-0907-2022 | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. |
| Jan 24, 2022 | Class I | Z-0662-2022 | Process control | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient.… |
| Jan 24, 2022 | Class I | Z-0663-2022 | Process control | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient.… |
| Apr 24, 2017 | Class I | Z-2061-2017 | Device Design | Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts… |
| Feb 1, 2017 | Class II | Z-1687-2017 | Device Design | The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E.… |
| Jun 4, 2013 | Class I | Z-1537-2013 | Software design | Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause… |
| Jul 31, 2012 | Class I | Z-2260-2012 | Nonconforming Material/Component | Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could… |
The 5 latest of 9 recalls; the web page lists all.
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.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K213521 (Nihon Kohden Orangemed, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K082660.
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. 2011, 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?
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician. The ventilator is intended to…
Read the full statement (131 words)
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician.
The ventilator is intended to support pediatric patients weighing 20 kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102985 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102985
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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