510(k) · Cleared
Recalled · Class I · 2021V60 Ventilator, Model V8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics California, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Jan 9, 2009 as substantially equivalent to K982454 (Respironics, Inc., 1998) and 2 other predicates after a 119-day review. Its family tree reaches back 4 generations to 1983. 7 of the 32 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 44 times, including 3 Class I recalls.
- Decided
- Jan 9, 2009
- Review
- 119 days
- Class
- Class II
- Product code
- MNT
- Recalls
- 44 (3 Class I)
- Predicates
- 3
Its longest line of descent runs back 4 generations to K833786 (1983). 17 ancestors in all, the oldest K811102 (1981). 14 later devices descend from it, 3 citing it directly. 7 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 2 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 1 generation backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- This deviceK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK102985 V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK213521 Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
2011high 3 (2025) · low 0 (2013)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · cites it directly8descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · cites it directly4descendants
- K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −3 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −2 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −1 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| 0 (this device) | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | — |
| +1 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +2 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +1 | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software Options | Respironics, Inc. | 2011 | Class I |
| +2 | K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022 | — |
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 |
|---|---|---|
| 2011 | 1 | 1 |
| 2012 | 2 | 2 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
7 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? (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 | Decided |
|---|---|---|---|
| * | K982454 | Bipap Vision Ventilatory SupportSummary page 1…- MNT Panel: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (73) Predicate Device: Vision Ventilator with Auto-Trak (K982454) BiPAP Synchrony with AVAPS (K070328) Esprit Ventilator (K981072) Indications for Use: The V60 ventilator is an a… | 1998 |
| * | K070328 | Bipap Synchrony with AvapsSummary page 1…neral Hospital, Infection Control and Dental Devices (73) Predicate Device: Vision Ventilator with Auto-Trak (K982454) BiPAP Synchrony with AVAPS (K070328) Esprit Ventilator (K981072) Indications for Use: The V60 ventilator is an assist ventilator and is intended to augment… | 2007 |
| * | K981072 | Esprit VentilatorSummary page 1…nd Dental Devices (73) Predicate Device: Vision Ventilator with Auto-Trak (K982454) BiPAP Synchrony with AVAPS (K070328) Esprit Ventilator (K981072) Indications for Use: The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended f… | 1998 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2021 | Class II | Z-1137-2021 | Under Investigation by firm | Due to unqualified "design verification" batteries being shipped to customers. |
| Nov 2, 2020 | Class II | Z-0902-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0903-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0906-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0911-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0915-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0916-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0907-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0904-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0905-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0910-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0914-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0908-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0909-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0912-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0913-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Nov 2, 2020 | Class II | Z-0917-2021 | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically… |
| Oct 30, 2020 | Class II | Z-0886-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0885-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0889-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0890-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0892-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0893-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0895-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0896-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0898-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0887-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0888-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0891-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0894-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0897-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0899-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0900-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Oct 30, 2020 | Class II | Z-0901-2021 | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. |
| Mar 5, 2020 | Class II | Z-1622-2020 | Under Investigation by firm | Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative… |
| Sep 11, 2019 | Class II | Z-1155-2020 | Other | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior… |
| Sep 11, 2019 | Class II | Z-1154-2020 | Other | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior… |
| Sep 11, 2019 | Class II | Z-1152-2020 | Other | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior… |
| Sep 11, 2019 | Class II | Z-1153-2020 | Other | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior… |
| 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… |
| 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… |
| Jul 2, 2010 | Not classified | Z-0457-2011 | Device Design | Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage. |
| Oct 26, 2009 | Not classified | Z-0176-2010 | Device Design | The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the… |
The 5 latest of 44 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.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 6 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K113053 (Respironics, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K982454.
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. 2009, this device’s year, is highlighted.
FDA decisions per year · MNT
1in 2025
2007high 2 (2009) · low 0 (2007)2026
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
2007high 33 (2020) · low 0 (2008)2026
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
2007high 9,350 (2019) · low 29 (2009)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 is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or…
Read the full statement (123 words)
The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) 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/K082660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082660: V60 Ventilator, Model V8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082660
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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