CirQPOD Intrathoracic Pressure Regulator

The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients. The CirQPOD…

Registry build 21.09.26

The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients. The CirQPOD employs a single use, disposable blower device connected to the CirQPOD Motor – used in combination with a ventilator source – to deliver a positive pressure breath (ventilation) to a patient. The CirQPOD’s mechanism of action derives from the physiologic principle that lower intrathoracic pressure will increase venous return to the heart. The increase in venous return results in increased cardiac output, circulation, and blood pressure. When inserted within a standard respiratory circuit between the patient and a ventilation source, the CirQPOD generates negative pressure during the expiratory phase to create sub-atmospheric intrathoracic pressure between the periods of positive pressure ventilations.

3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code BWF
Manufacturer City Province Registered as Device types
Shenzhen Ainengke Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 9
Chinamed Products (China) Ltd. Gaoyao District Guangdong Manufacturer 8
Shenzhen Gwode Technology Co., Ltd. Shenzhen Guangdong Repacker / relabeller 2

Record

Regulatory record for CirQPOD Intrathoracic Pressure Regulator
Listed by Advanced Circulatory Systems, Inc., United States
FDA product code BWF
Device type Spirometer, Therapeutic (Incentive)
Device class Class 2
Regulation 21 CFR 868.5690
510(k) K172388
Record published 2018-08-23

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for CirQPOD Intrathoracic Pressure Regulator
Catalogue number Size Status
12-2415-000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Portex ICU Medical, Inc 42
Hudson RCI Teleflex Medical LLC 26
AirLife™ Airlife, Inc. 11
AIM Vitalograph Ireland Ltd. 9
AirLife Carefusion 8
Prochamber Assembly Respironics Respiratory Drug Delivery (Uk), Ltd. 6
Threshold Respironics Respiratory Drug Delivery (Uk), Ltd. 6
Curaplex Bound Tree Medical, LLC 5
Hudson RCI Medline Industries, Inc. 5
VersaPAP™ Positive Airway Pressure Device Trudell Medical International 4
Curaplex TRI-Anim Health Services, Inc. 4
Halyard Owens & Minor Distribution, Inc. 4

Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K070490 2007-06-20
K040084 2004-04-07
K033401 2003-11-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer