Company ยท US
Newport Medical Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2012. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2012 | K121891 | NEWPORT AURA VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Dec 1, 2011 | K111146 | NEWPORT HT70 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Sep 8, 2010 | K101803 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Nov 18, 2009 | K090888 | NEWPORT HT70 FAMILY OF VENTILATORS Newport Medical Instruments, Inc. | CBK |
| Dec 16, 2008 | K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM Newport Medical Instruments, Inc. | CBK |
| Jul 28, 2006 | K061094 | NEWPORT E500 WAVE VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Jan 10, 2006 | K053502 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Dec 15, 2004 | K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 Newport Medical Instruments | BTI |
| Sep 7, 2004 | K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER Newport Medical Instruments, Inc. | CAF |
| Jan 23, 2004 | K030780 | NEWPORT E500 WAVE VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Aug 4, 2000 | K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL Newport Medical Instruments, Inc. | CBK |
| Sep 23, 1999 | K972833 | E100M VENTILATOR (E100M) Newport Medical Instruments, Inc. | CBK |
| Aug 25, 1995 | K941308 | NEWPORT ELECTRONIC MANOMETER Newport Medical Instruments, Inc. | CBK |
| Mar 7, 1995 | K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR Newport Medical Instruments, Inc. | MOD |
| Mar 6, 1995 | K941309 | NEWPORT ELECTRONIC MANOMETER Newport Medical Instruments, Inc. | CBK |
| Oct 25, 1993 | K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR Newport Medical Instruments, Inc. | BZK |
| Aug 10, 1990 | K901785 | NEWPORT WAVE VENTILATOR MODEL E200 Newport Medical Instruments, Inc. | CBK |
| Jun 23, 1989 | K883809 | NEWPORT VENTILATOR MODEL E150 Newport Medical Instruments, Inc. | CBK |
| May 21, 1986 | K860373 | THE M100 AIR/OXYGEN MIXER Newport Medical Instruments, Inc. | BZR |
| May 6, 1986 | K860438 | NEWPORT VENTILATOR MODEL E-100 Newport Medical Instruments, Inc. | CBK |
| Sep 18, 1985 | K852108 | NEWPORT VENTILATOR MODEL E-100 Newport Medical Instruments, Inc. | |
| Dec 27, 1984 | K844350 | NEWPORT VENTILATOR MODEL E-100 Newport Medical Instruments, Inc. | CBK |
| Apr 16, 1982 | K820746 | NEWPORT VENTILATOR MODEL E100 Newport Medical Instruments, Inc. | CBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2017 | Newport Medical Instruments Inc Newport Medical HT70 and HT70- Plus Ventilators, Rx Only
Product Usage:
The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilat Terminated |
CBK | K090888 K111146 |
| Apr 14, 2014 | Newport Medical Instruments Inc Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus.
Product Usage:
The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ven Terminated |
CBK | K090888 K111146 |
| Apr 26, 2013 | Newport Medical Instruments Inc Newport Medical Instruments HT70
and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus.
The HT70 and HT70 Plus ventilator systems are intended to provide continuous or inter Terminated |
CBK | K090888 K111146 |
| Jun 8, 2011 | Newport Medical Instruments Inc Newport e360 Ventilator, Model Number: e360
The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and moni Terminated |
CBK | K053502 |
| Jun 2, 2011 | Newport Medical Instruments Inc Newport HT70 Ventilator. Model #HT70,
The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who Terminated |
CBK | K090888 |
| May 27, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B
Product Code: NOU
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of Terminated |
CBK | K082724 |
| May 26, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator.
Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B.
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who Terminated |
CBK | K992133 |
| May 26, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator. Model #HT50 H1-B
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Terminated |
CBK | K992133 |
| May 19, 2010 | Newport Medical Instruments Inc Newport e360 Ventilator
The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, p Terminated |
CBK | K053502 |
| Sep 4, 2009 | Newport Medical Instruments Inc Newport e360 Ventilator, Rx only.
The e360 Ventilator System is intended to provide continuous
(endotracheal or tracheostomy [ET] tube) or non-continuous
(mask) ventilatory support and monitoring fo Terminated |
CBK | K053502 |
| Sep 19, 2007 | Newport Medical Instruments Inc Newport HT50 Ventilator (all Models) Terminated |
CBK | K992133 |
| Aug 17, 2005 | Newport Medical Instruments Inc Newport HT50 All Purpose Ventilator Terminated |
CBK | K992133 |