510(k) · Cleared
ClearedNewport E500 Wave 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 Jul 28, 2006 as substantially equivalent to K030780 (Newport Medical Instruments, Inc., 2004) and 3 other predicates after a 100-day review. Its family tree reaches back 7 generations to 1991. 4 of the 33 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jul 28, 2006
- Review
- 100 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K902859 (1991). 30 ancestors in all, the oldest K902506 (1991). 2 later devices descend from it, 1 citing it directly. 4 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK961687 EVITA 4Drager, Inc. · 1996
- 5 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 2 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 1 generation backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- This deviceK061094 Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK101803 Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK121891 Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
Class I recalls in this family
- K041223 Modification to Servo-I Ventilator System, Model…direct predicate · 2004
- K984535 Puritan-Bennett 840 Ventilatory System with…direct predicate · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…2 generations back · 1998
- K001646 Puritan-Bennett 840 Ventilator System with…3 generations back · 2000
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 |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −5 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| 0 (this device) | K061094 | Newport E500 Wave Ventilator | Newport Medical Instruments, Inc. | 2006 | — |
| +1 | K101803 | Newport E360 Ventilator | Newport Medical Instruments, Inc. | 2010 | — |
| +2 | K121891 | Newport Aura Ventilator | Newport Medical Instruments, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 1 |
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.
4 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 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? (4)
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…tra-hospital transport includes patient transport within the hospital or hospital-type facility. F. Cleared/Predicate Device Cleared Device Newport e500 Ventilator, K030780 Predicate Devices Drager EvitaXL K051263, July 12th, 2005 Maquet Servo-I Ventilator, K041223, July 29th, 2004 Puritan-Bennett 840… | 2004 |
| * | K051263 | Evitaxl with Option SmartcareSummary page 2…ransport within the hospital or hospital-type facility. F. Cleared/Predicate Device Cleared Device Newport e500 Ventilator, K030780 Predicate Devices Drager EvitaXL K051263, July 12th, 2005 Maquet Servo-I Ventilator, K041223, July 29th, 2004 Puritan-Bennett 840, K984535, December 28, 1998 G. Summa… | 2005 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 2…ty. F. Cleared/Predicate Device Cleared Device Newport e500 Ventilator, K030780 Predicate Devices Drager EvitaXL K051263, July 12th, 2005 Maquet Servo-I Ventilator, K041223, July 29th, 2004 Puritan-Bennett 840, K984535, December 28, 1998 G. Summary of Substantial Equivalence The Newport e500 Wave… | 2004 |
| * | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel OptionSummary page 2…evice Newport e500 Ventilator, K030780 Predicate Devices Drager EvitaXL K051263, July 12th, 2005 Maquet Servo-I Ventilator, K041223, July 29th, 2004 Puritan-Bennett 840, K984535, December 28, 1998 G. Summary of Substantial Equivalence The Newport e500 Wave Ventilator is substantially equivalent to the… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101803 | Newport E360 Ventilator | 2010 | 1 |
Has anything in its family been recalled? (4 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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 30 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K101803 (Newport Medical Instruments, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K030780.
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 e500 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 e500 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/K061094 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061094: Newport E500 Wave Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061094
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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