Data / Medical devices / United States / Covidien
Covidien: FDA-registered device maker in Carlsbad, CA, United States, 32 510(k) clearances
Covidien is registered with the FDA (registration 2024500) in Carlsbad, CA, United States. It lists 16 device types. The FDA files 32 510(k) clearances under its listings, the newest dated November 20, 2020. 3 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024500
- Address
- 2101 Faraday Avenue, Carlsbad, CA, United States, 92008
- Owner or operator
- Covidien llc (1282497)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 23, 1991
- Registered through
- 2026
- Brand names listed
- 840 Vent with VV+, Breeze Sleepgear with Dreamseal, Capno-Flo, Clinivision, Compressor, DC compressor, DMR Plus Disposable Manual, HT70 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 |
|---|---|---|---|---|---|---|
| November 20, 2020 | K193056 | Puritan Bennett 980 Series Ventilator System | CBK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 15, 2020 | K193058 | SonarMed AirWave Airway Monitoring System | OQU | Substantially Equivalent | Sonarmed, Inc. | accessdata.fda.gov |
| March 29, 2016 | K151252 | Puritan Bennett 840 Series Ventilator System | CBK | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| November 9, 2012 | K121891 | NEWPORT AURA VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| December 1, 2011 | K111146 | NEWPORT HT70 VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| September 8, 2010 | K101803 | NEWPORT E360 VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| December 16, 2008 | K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| March 31, 2008 | K073706 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. | accessdata.fda.gov |
| July 28, 2006 | K061094 | NEWPORT E500 WAVE VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| December 15, 2004 | K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | BTI | Substantially Equivalent | Newport Medical Instruments | accessdata.fda.gov |
| September 7, 2004 | K041082 | NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER | CAF | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| January 23, 2004 | K030780 | NEWPORT E500 WAVE VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| February 7, 2003 | K023494 | NELLCOR INDGO MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 27, 2002 | K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | BZG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| August 13, 2002 | K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION | CBK | Substantially Equivalent - Subject to Tracking Reg. | Puritan-Bennett | accessdata.fda.gov |
| October 18, 2000 | K002686 | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E | CBK | Substantially Equivalent - Subject to Tracking Reg. | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 6, 2000 | K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | BZD | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| April 19, 2000 | K993268 | MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT | BTT | Substantially Equivalent | Mallinckrodt Dar S.R.L. | accessdata.fda.gov |
| September 23, 1999 | K972833 | E100M VENTILATOR (E100M) | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| March 25, 1998 | K973419 | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| August 25, 1995 | K941308 | NEWPORT ELECTRONIC MANOMETER | CBK | Substantially Equivalent - Subject to Tracking Reg. | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| July 7, 1995 | K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| March 7, 1995 | K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | MOD | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| March 6, 1995 | K941309 | NEWPORT ELECTRONIC MANOMETER | CBK | Substantially Equivalent - Subject to Tracking Reg. | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| October 25, 1993 | K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | BZK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| October 6, 1993 | K933626 | CAPNO-FLO | BTM | Substantially Equivalent | Kirk Specialty Systems | accessdata.fda.gov |
| January 13, 1992 | K913368 | MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC | BTT | Substantially Equivalent | Fisher & Paykel Electronics , Ltd. | accessdata.fda.gov |
| August 10, 1990 | K901785 | NEWPORT WAVE VENTILATOR MODEL E200 | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| June 23, 1989 | K883809 | NEWPORT VENTILATOR MODEL E150 | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| May 21, 1986 | K860373 | THE M100 AIR/OXYGEN MIXER | BZR | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| December 17, 1980 | K802813 | PMR-2 PURITAN MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| November 19, 1976 | K760923 | HUMIDIFIER-CASCADE II | BTT | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 21, 2025 | 96774 | Class I | Ongoing | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-B | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen | accessdata.fda.gov |
| June 24, 2024 | 94855 | Class I | Ongoing | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 V | Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some | accessdata.fda.gov |
| August 31, 2006 | 36306 | Not yet classified | Terminated | Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD | Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Continuous, Facility Use
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Compressor, Air, Portable
- All makers of Spirometer, Diagnostic
Updated June 9, 2025. 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.