510(k) · Cleared
Recalled · 2010Newport E360 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newport Medical Instruments, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 10, 2006 as substantially equivalent to K030780 (Newport Medical Instruments, Inc., 2004) after a 25-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 10, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030780 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030780 Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2004
- This deviceK053502 Newport E360 VentilatorNewport Medical Instruments, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK101803 Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK121891 Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
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 |
|---|---|---|---|---|---|
| −1 | K030780 | Newport E500 Wave Ventilator | Newport Medical Instruments, Inc. | 2004 | — |
| 0 (this device) | K053502 | Newport E360 Ventilator | Newport Medical Instruments, Inc. | 2006 | — |
| +1 | K101803 | Newport E360 Ventilator | Newport Medical Instruments, Inc. | 2010 | — |
| +1 | K121891 | Newport Aura Ventilator | Newport Medical Instruments, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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.
Planning a device in CBK? 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 |
|---|---|---|---|
| * | K030780 | Newport E500 Wave VentilatorSummary page 2…he hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility. F. Cleared/Predicate Device Newport e500 Ventilator (K030780). G. Summary of Substantial Equivalence The Newport e360 Ventilator is substantially equivalent to the cleared/predicate devi… | 2004 |
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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2010 | Not classified | Z-1617-2010 | Other | The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. Ventilators manufactured between… |
| Oct 27, 2009 | Not classified | Z-2468-2011 | Mixed-up of materials/components | Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered. |
| Dec 15, 2008 | Not classified | Z-2029-2009 | Software design | In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms.… |
No ancestor or descendant has a Class I recall.
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.
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 e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of > 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical…
Read the full statement (99 words)
The e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of > 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053502: Newport E360 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053502
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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