Company ยท US
Westmed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2016. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
26recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBT | Arterial Blood Sampling Kit | 14 |
| KGB | Mask, Oxygen, Non-Rebreathing | 6 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 |
| BYG | Mask, Oxygen | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery Westmed, Inc. | CCK |
| Aug 11, 2015 | K143148 | Disposable Pressure Manometer (DPM) Westmed, Inc. | CAP |
| May 23, 2014 | K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR Westmed, Inc. | SDT |
| Dec 6, 2012 | K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] Westmed, Inc. | CAH |
| Jul 15, 2008 | K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP Westmed, Inc. | MEB |
| Aug 23, 2007 | K072220 | PEDI CO2 EASY Westmed, Inc. | CCK |
| Feb 15, 2007 | K070128 | CO2 EASY Westmed, Inc. | CCK |
| Sep 18, 1995 | K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK Westmed, Inc. | BYG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Westmed, Inc. 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, corrug Open, Classified |
BZA | None listed |
| Nov 11, 2020 | Westmed, Inc. REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to conn Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: inte Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to th Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. 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 Terminated |
KGB | K913164 |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | K923618 |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | K923618 |
| Jan 15, 2019 | Westmed, Inc. 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. Terminated |
BYE | K923618 |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95.
An arterial blood sampling kit i Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98.
An arterial blood sampling kit is a device, in k Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95.
An arterial blood sampling kit is a device, in kit for Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393.
An arterial blood sampling kit is a device, in kit form, us Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95.
An arterial blood sampling kit is a device, in kit for Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372.
An arterial blood sampling kit is a device, in kit form, used to Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel,
25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S.
An arte Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95.
An arterial blood sampling kit is a device, in kit form, used t Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95.
An arterial blood sampling Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95.
An arterial blood sampling kit is a device, in kit Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98.
An arterial blood sampling kit is a device, in k Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14.
An arterial blood sampling kit is a device, in kit form, used Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc Pulset Arterial Blood Gas (ABG) sampling kit.
Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98.
An arterial blood sampling kit is a device, Terminated |
CBT | None listed |
| Oct 20, 2012 | Westmed Inc 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 k Terminated |
CBT | None listed |
| Sep 8, 2010 | Westmed Inc 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 breathi Terminated |
BTM | K934310 K940581 |
| Sep 8, 2010 | Westmed Inc 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 breathi Terminated |
BTM | K934310 K940581 |