Newport Medical Instruments, Inc.
Costa Mesa, CA, US
Newport Medical Instruments, Inc. appears in FDA device records in Costa Mesa, CA. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 12 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Newport Medical Instruments, Inc. between 1982 and 2012. The busiest year on record is 1995, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1995 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| 2004 | 3 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121891 | NEWPORT AURA VENTILATOR | CBK | Substantially Equivalent | |
| K111146 | NEWPORT HT70 VENTILATOR | CBK | Substantially Equivalent | |
| K101803 | NEWPORT E360 VENTILATOR | CBK | Substantially Equivalent | |
| K090888 | NEWPORT HT70 FAMILY OF VENTILATORS | CBK | Substantially Equivalent | |
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | CBK | Substantially Equivalent | |
| K061094 | NEWPORT E500 WAVE VENTILATOR | CBK | Substantially Equivalent | |
| K053502 | NEWPORT E360 VENTILATOR | CBK | Substantially Equivalent | |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | BTI | Substantially Equivalent | |
| K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | CAF | Substantially Equivalent | |
| K030780 | NEWPORT E500 WAVE VENTILATOR | CBK | Substantially Equivalent | |
| K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K972833 | E100M VENTILATOR (E100M) | CBK | Substantially Equivalent | |
| K941308 | NEWPORT ELECTRONIC MANOMETER | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | MOD | Substantially Equivalent | |
| K941309 | NEWPORT ELECTRONIC MANOMETER | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | BZK | Substantially Equivalent | |
| K901785 | NEWPORT WAVE VENTILATOR MODEL E200 | CBK | Substantially Equivalent | |
| K883809 | NEWPORT VENTILATOR MODEL E150 | CBK | Substantially Equivalent | |
| K860373 | THE M100 AIR/OXYGEN MIXER | BZR | Substantially Equivalent | |
| K860438 | NEWPORT VENTILATOR MODEL E-100 | CBK | Substantially Equivalent | |
| K852108 | NEWPORT VENTILATOR MODEL E-100 | Substantially Equivalent | ||
| K844350 | NEWPORT VENTILATOR MODEL E-100 | CBK | Substantially Equivalent | |
| K820746 | NEWPORT VENTILATOR MODEL E100 | CBK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1874-2017 | 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 ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm. | Class I | Terminated | |
| Z-1171-2013 | 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 intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. | Class I | Terminated | |
| Z-2250-2012 | 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 ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. | May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. | Class I | Terminated | |
| Z-2406-2011 | 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 require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications. | The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di | Terminated | ||
| Z-2382-2011 | 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 require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs) | The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. | Terminated | ||
| Z-1617-2010 | 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, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription 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, emergency rooms, 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. | 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 September and December 2009 are affected by this field correction. All affected ventilators require the replacement of the PCB2104A board to avoid early failure of t | Terminated | ||
| Z-2468-2011 | 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 monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription 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, emergency rooms, 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. | Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered. | Terminated | ||
| Z-2384-2011 | 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 individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. | The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has a slightly higher amperage draw than the single battery and as a result can cause the fuse in the external battery pack to blow making the battery inoperable. | Terminated | ||
| Z-2295-2011 | 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. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support. | The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. | Terminated | ||
| Z-2029-2009 | 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 for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). | 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. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu | Terminated | ||
| Z-1192-2007 | Newport HT50 Ventilator (all Models) | Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new. | Terminated | ||
| Z-1375-05 | Newport HT50 All Purpose Ventilator | Lack of alarm prior to shutdown. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain