510(k) · Cleared
Recalled · Class II · 2021Nihon Kohden NKV-550 Series Ventilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Orangemed, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 7, 2018 as substantially equivalent to K093633 (Draegerwerk AG & CO Kgaa, 2010) after a 163-day review. Its family tree reaches back 1 generation to 2010. 1 of the 6 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 7, 2018
- Review
- 163 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093633 (2010). 4 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK093633 Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Recalled (Class I)
- This deviceK181695 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK192307 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK222644 Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK251165 Saans (F4-01-00-000-000)Innaccel Technologies Private Limited · 2026
- Descendant · 2 generations on · 0 of its ownK231778 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC · 2024
Class I recalls in this family
- K093633 Infinity Acute Care System Workstation Critical…direct predicate · 2010
Most influential descendants
Showing 4 of 4 · See all- K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020 · cites it directly3descendants
- K222644Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. · 2023 · 2 generations on1descendant
- K251165Saans (F4-01-00-000-000)Innaccel Technologies Private Limited · 2026 · 3 generations on0descendants
- K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093633 | Infinity Acute Care System Workstation Critical Care | Draegerwerk AG & CO Kgaa | 2010 | Class I |
| 0 (this device) | K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018 | — |
| +1 | K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020 | 1 |
| +2 | K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023 | — |
| +3 | K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | 2026 | — |
| +2 | K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
1 device in this family has 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 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? (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 |
|---|---|---|---|
| * | K093633 | Infinity Acute Care System Workstation Critical CareSummary page 5…Sec. 5 - 510(k) Summary Predicate Device Product: Evita Infinity® V500 510k #: k093633 Manufacturer: Draegerwerk AG & Co. KGaA Establishment Reg. #: 9611500 Device Description The Nihon Kohden NK… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | 2020 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2021 | Class II | Z-2435-2021 | Nonconforming Material/Component | Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior… |
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.
- K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181695: Nihon Kohden NKV-550 Series Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181695
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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