Model 7200AE Ventilator Flow by 2.0 or Option 50
by Puritan Bennett Corp. 510(k)
Active
510(k) K920002
Overview
The Model 7200AE is a continuous-use ventilator designed for facility-based respiratory support. As classified under the FDA’s device nomenclature, it provides mechanical ventilation for patients requiring assisted or controlled breathing, including those in critical care settings. This device delivers controlled or pressure-assisted ventilation with adjustable flow and pressure settings to meet varying clinical needs, such as anesthesia support or acute respiratory failure management.
Intended for hospital or clinical facility use, the Model 7200AE is a reusable device with regulatory clearance through the FDA’s 510(k) pathway, specifically under the Anesthesiology advisory committee. It operates in environments requiring sterile or clean conditions and is not intended for single-patient-use applications. The device’s compliance with FDA regulations (regulation number 868.5895) ensures adherence to safety and performance standards for ventilatory support. No MRI safety information or specific size variations are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920002 | Date10 Nov 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the Model 7200AE ventilator designed for?
The Model 7200AE ventilator is designed for facility-based respiratory support, providing mechanical ventilation for patients requiring assisted or controlled breathing. It is particularly suited for critical care settings, anesthesia support, and managing acute respiratory failure. The device offers adjustable flow and pressure settings to accommodate varying clinical needs.
Is the Model 7200AE ventilator intended for single-patient use?
No, the Model 7200AE ventilator is not intended for single-patient use. It is classified as a reusable device, meaning it is designed for repeated use in clinical environments where sterile or clean conditions are maintained. This aligns with its FDA clearance for facility-based applications.
What regulatory pathway does the Model 7200AE ventilator follow?
The Model 7200AE ventilator has received FDA clearance through the 510(k) pathway, specifically under the Anesthesiology advisory committee. This clearance ensures the device meets safety and performance standards for ventilatory support, as outlined in FDA regulation number 868.5895. The device is classified under the Anesthesiology medical specialty.
What types of environments is the Model 7200AE ventilator suitable for?
The Model 7200AE ventilator is intended for hospital or clinical facility use where sterile or clean conditions are required. It is not designed for home use or single-patient applications, emphasizing its role in controlled, professional healthcare settings.
Are there specific size variations or MRI safety information for the Model 7200AE ventilator?
The regulatory data for the Model 7200AE ventilator does not mention specific size variations or MRI safety information. The device is designed for general facility-based use with adjustable settings to meet clinical needs, but no additional size-specific details or MRI compatibility are provided.