510(k) Report

510(k) · Cleared

Cleared

Newport E500 Wave Ventilator

K030780510(k) TraditionalCleared Jan 23, 2004318-day reviewClass II21 CFR 868.5895

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Newport Medical Instruments, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Jan 23, 2004 after a 318-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.

Decided
Jan 23, 2004
Review
318 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK030780 Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2004
  2. Descendant · cites it directly · 2 of its ownK061094 Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2006
  3. Descendant · cites it directly · 2 of its ownK053502 Newport E360 VentilatorNewport Medical Instruments, Inc. · 2006 · Recalled
  4. Descendant · cites it directly · 1 of its ownK101803 Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010
  5. Descendant · 2 generations on · 0 of its ownK121891 Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012

Most influential descendants

Showing 4 of 4 · See all
  • K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2006 · cites it directly2descendants
  • K053502Newport E360 VentilatorNewport Medical Instruments, Inc. · 2006 · cites it directly2descendants
  • K101803Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010 · cites it directly1descendant
  • K121891Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030780Newport E500 Wave VentilatorNewport Medical Instruments, Inc.2004—
+1K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.2006—
+1K053502Newport E360 VentilatorNewport Medical Instruments, Inc.20063
+1K101803Newport E360 VentilatorNewport Medical Instruments, Inc.2010—
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201010
201210
FIG. 1 — Lineage of K030780, 2004–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—E200 Ventilator
Named without a submission number
—
*—Siemens Servo Ventilators
Named without a submission number
—

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062
K053502Newport E360 VentilatorNewport Medical Instruments, Inc.20062
K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061094 (Newport Medical Instruments, Inc., 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

What is it indicated for?

The e500 Ventilator is intended to provide continuous (ET tube) or noncontinuous (mask) ventilatory support and monitoring for infant, pedatric and adult patients with a tidal volume of > 20 mL. The device is prescription use only. The intended environments include hospital, hospitaltype and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care…

Read the full statement (99 words)

The e500 Ventilator is intended to provide continuous (ET tube) or noncontinuous (mask) ventilatory support and monitoring for infant, pedatric and adult patients with a tidal volume of > 20 mL. The device is prescription use only.

The intended environments include hospital, hospitaltype 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.

More from Newport Medical Instruments, Inc.

22 FDA decisions under this applicant name. See the company

  • K121891Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
  • K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 20114 Class I recalls
  • K101803Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010
  • K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 20093 Class I recalls
  • K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 20082 recalls

Recent decisions in CBK

The CBK category page

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https://510kreport.com/device/K030780 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030780: Newport E500 Wave Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030780

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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