Data / Medical devices / United States / Westmed, Inc.
Westmed, Inc.: FDA-registered device maker in Tucson, AZ, United States, 35 510(k) clearances
Westmed, Inc. is registered with the FDA (registration 2028807) in Tucson, AZ, United States. It lists 46 device types. The FDA files 35 510(k) clearances under its listings, the newest dated December 14, 2016. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028807
- FEI number
- 1000374126
- Address
- 5580 S Nogales Hwy, Tucson, AZ, United States, 85706
- Owner or operator
- WESTMED, INC. (9006543)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- November 13, 1992
- Registered through
- 2026
- Brand names listed
- A-line, AEROSOL CHARGING ADAPTOR, AIRWAY EXTENSION, Adult BagEasy, Anapod, Anesthesia Breathing Circuit Kit, Arterial Blood Gas (ABG), Westmed, BARBED CONNECTOR 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 |
|---|---|---|---|---|---|---|
| December 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| March 13, 2013 | K130091 | PULMOSAL | CAF | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| December 6, 2012 | K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | CAH | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| September 12, 2011 | K110713 | WATERPAP VALVE | BYE | Substantially Equivalent | Airways Development, LLC | accessdata.fda.gov |
| November 20, 2009 | K091862 | NESSI SPACER | NVO | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| August 23, 2007 | K072220 | PEDI CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| February 15, 2007 | K070128 | CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| July 22, 2004 | K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| June 3, 2004 | K040712 | AIR SAFETY HEPA, MODEL 3500 | MOD | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| October 7, 2003 | K031413 | VIGORMIST COMPRESSOR NEBULIZER | BTI | Substantially Equivalent | Vega Technologies, Inc. | accessdata.fda.gov |
| March 11, 1998 | K973238 | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER | CAH | Substantially Equivalent | Bill Olson Corp. | accessdata.fda.gov |
| December 16, 1996 | K963910 | HEART NEBULIZER #100609 | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| March 27, 1996 | K955047 | WESTMED CIRCULARIE PEP DEVICES | BYE | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| December 28, 1995 | K954271 | WESTMED CONDESATE COLLECTION TRAP | CAW | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| April 24, 1995 | K951484 | WESTMED BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| December 5, 1994 | K944941 | PISTON SYRINGE | CBT | Substantially Equivalent | Martell Medical Products, Inc. | accessdata.fda.gov |
| October 13, 1994 | K943600 | UNIHEART | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| May 6, 1994 | K940581 | BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS | BTM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 1993 | K934310 | BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| August 26, 1993 | K924667 | AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| August 3, 1993 | K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | JKA | Substantially Equivalent | Martech Medical Products, Inc. | accessdata.fda.gov |
| July 23, 1993 | K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | BZR | Substantially Equivalent | Precision Med Products, Ltd. | accessdata.fda.gov |
| February 3, 1993 | K926055 | THE MILLER NEBULIZER SYSTEM | CAF | Substantially Equivalent | Warren C. Miller | accessdata.fda.gov |
| January 15, 1993 | K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | LYA | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| October 15, 1992 | K923596 | HEART NEBULIZER | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| September 16, 1992 | K914778 | NEOLINE(TM) | CBT | Unknown | Martech Medical Products, Inc. | accessdata.fda.gov |
| August 24, 1992 | K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| August 3, 1992 | K923618 | PEEP VALVE | BYE | Substantially Equivalent | International Respiratory Systems, Inc. | accessdata.fda.gov |
| July 2, 1992 | K920443 | MININEB | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| February 3, 1992 | K913163 | NON REBREATHING VALVE | CBP | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| April 24, 1991 | K904538 | MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT | CAI | Substantially Equivalent | Mauna Loa Medical, Inc. | accessdata.fda.gov |
| June 10, 1988 | K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE | BZE | Substantially Equivalent | Simplex Medical Corp. | accessdata.fda.gov |
| April 3, 1987 | K870173 | LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL | BTT | Substantially Equivalent | Mauna Loa Medical, Inc. | accessdata.fda.gov |
| October 21, 1982 | K822786 | MDM ARTERIAL BLOOD GAS KIT | CBT | Substantially Equivalent | Martell Medical Products, Inc. | accessdata.fda.gov |
| March 25, 1980 | K800562 | DISPOSABLE HAND HELD NEBULIZER | CAF | Substantially Equivalent | Intec Medical, 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 |
|---|---|---|---|---|---|---|
| September 27, 2024 | 95453 | Class II | Ongoing | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes tha | Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death. | accessdata.fda.gov |
| November 11, 2020 | 86903 | Class II | Terminated | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment. | accessdata.fda.gov |
| January 15, 2019 | 85576 | Class II | Terminated | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits. | accessdata.fda.gov |
| January 18, 2011 | 63276 | Class II | Terminated | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtai | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | accessdata.fda.gov |
| June 22, 2010 | 56162 | Not yet classified | Terminated | BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a fac | This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device. | accessdata.fda.gov |
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Updated October 30, 2024. 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.