510(k) · Cleared
ClearedNihon Kohden NKV-330 Ventilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Orangemed, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Jul 1, 2022 as substantially equivalent to K102985 (Respironics, Inc., 2011) after a 240-day review. Its family tree reaches back 6 generations to 1983. 3 of the 22 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jul 1, 2022
- Review
- 240 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). 2 later devices descend from it, 2 citing it directly. 3 of the 22 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 deviceK213521 Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252182 SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242931 HFT750UMekics Co., Ltd. · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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) | K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022 | — |
| +1 | K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | — |
| +1 | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software OptionsSummary page 4…siology 7. Predicate Device Predicate Device Product: V60 Ventilator with PPV and Auto-Trak + Software Options 510k #: k102985 Manufacturer: Respironics California, LLC File: 510(k) Summary.docx… | 2011 |
| † | K181695 | Nihon Kohden NKV-550 Series Ventilator System | 2018 |
What descends from it? (2)
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)
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 39 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.
- Of its descendants, K252182 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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 Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospitals, hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213521: Nihon Kohden NKV-330 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/K213521
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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