Data / Medical devices / United States / Respironics Novametrix, LLC
Respironics Novametrix, LLC: FDA-registered device maker in Andover, MA, United States, 14 510(k) clearances
Respironics Novametrix, LLC is registered with the FDA (registration 1219324) in Andover, MA, United States. It lists 17 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 4, 2020. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219324
- Address
- 3000 Minuteman Rd., Andover, MA, United States, 01810
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Specification developer
- First device listed
- November 10, 2003
- Registered through
- 2026
- Brand names listed
- 15mm Male/Female Adapter, 15mm Male/Female Adapter Low Deadspace, AA &TRAY ASSY, ADU, ZOLL MED 8000-0262, ADULT AIRWAY ADAPTER, QTY 1, MAQUET, AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10, Adapter ADU Reuse Capnostat 704-0002-00, Adult Nasal/Oral CO2 Cannula Capnoflex, Airway Adapter - Single Patient Use - Adult/Pediatric and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 19, 2019 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| August 2, 2017 | K162832 | 731 Series Ventilators | CBK | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| June 20, 2014 | K123149 | SERVO-I VENTILATOR SYSTEM | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| June 2, 2011 | K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | BZK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| August 21, 2009 | K092217 | MERCURY VCO2 | BZK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| July 28, 2009 | K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | BZK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| March 23, 2009 | K083750 | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| February 17, 2006 | K060221 | THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| April 22, 2005 | K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| November 19, 2004 | K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| December 4, 2003 | K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR | MHX | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 29, 2011 | 59312 | Not yet classified | Terminated | PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHI | Pressure lines maybe occluded and display incorrect tidal volumes. | accessdata.fda.gov |
| January 4, 2011 | 57594 | Not yet classified | Terminated | Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual. | accessdata.fda.gov |
| August 11, 2006 | 36081 | Not yet classified | Terminated | NICO Model 7300 Cardiopulmonary Management System | Audible alarm may not sound during an alert condition | accessdata.fda.gov |
| September 2, 2002 | 29378 | Not yet classified | Terminated | Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5 | Audio alarm may fail to sound when SpO2 limits drop below the set limits | accessdata.fda.gov |
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Updated May 4, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.