510(k) Report

FDA applicant

Newport Medical Instruments, Inc.

Costa Mesa, CA23 decisions1982–201214 recalls

FDA records 23 decisions for Newport Medical Instruments, Inc. (Costa Mesa, CA) from 1982 to 2012: 23 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTI (Compressor, Air, Portable). Its devices cite 51 predicates, 13 of them its own earlier devices. 14 recalls are linked to its devices, 4 Class I.

FDA’s records also spell it “Newport Medical Instruments”.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Newport Medical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008: 12009: 12010: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12008: 12009: 32010: 32011: 12012: 1, 1 Class I2013: 1, 1 Class I2017: 1, 1 Class I2025: 1, 1 Class I
2007high 3 (2009) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Newport Medical Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Newport Medical Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use17decisions
  • BTICompressor, Air, Portable1decision
  • CAFNebulizer (Direct Patient Interface)1decision
  • MODAccessory To Continuous Ventilator (Respirator)1decision
  • BZKSpirometer, Monitoring (W/Wo Alarm)1decision
  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision

Whose devices does it build on?

Its devices cite 51 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K992133Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport…Newport Medical Instruments, Inc. · 20004cite it
  • K030780Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 20043cite it
  • K041406Newport C250 Air Compressor Model C250Newport Medical Instruments · 20042cite it
  • K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 20092cite it
  • K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 20082cite it
  • K053502Newport E360 VentilatorNewport Medical Instruments, Inc. · 20062cite it

What has FDA decided for it lately?

  • 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
  • K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2006
  • K053502Newport E360 VentilatorNewport Medical Instruments, Inc. · 20063 recalls
  • K041406Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004

All 22 as Newport Medical Instruments, Inc. →The one decision as Newport Medical Instruments →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K111146Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR…May 21, 2025Class I
  • K090888Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70…Mar 30, 2017Class I
  • K090888Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model…Apr 5, 2013Class I
  • K090888Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage…Aug 3, 2012Class I
  • K082724V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable…Aug 10, 2011
  • K090888Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide…Sep 20, 2010

Other applicant names beginning “Newport”

FDA records each applicant name separately; these may or may not be the same firm.

Newport Biosystems, Inc. 4Newport Bio Systems 1