F&P InfoSmart
by Fisher & Paykel Healthcare, Inc.
510(k) K161686
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161686 | Date24 Jan 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZD
- FDA applicant
- Fisher & Paykel Healthcare, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The F&P InfoSmart is a patient management system designed for use with Fisher & Paykel Healthcare CPAP devices, including the F&P ICON family and SleepStyle CPAPs. It provides comprehensive patient reporting and is compatible with various data communication methods such as telephone reporting, SmartStick, and Serial Cable.
The F&P InfoSmart is a cloud-based system for OSA therapy that digitally puts patient therapy and clinical management in the same room. It is designed to help identify patients with therapy or compliance issues and act upon the received information immediately. The device is authorized by FDA 510K and is classified as a Class 2 device.
Other devices from Fisher & Paykel Healthcare, Inc.
Questions
AI-generated answers, 1 Oct 2026
What clinical purpose does the F&P InfoSmart serve?
It provides comprehensive patient reporting for OSA therapy, allowing clinicians to identify compliance or therapy issues quickly and intervene promptly, which improves treatment outcomes for users of Fisher & Paykel CPAP machines.
How does the system transmit patient data?
Data can be sent through several communication methods—including telephone reporting, the SmartStick accessory, or a serial cable—so it can integrate with existing clinic workflows and ensure timely access to therapy information.
Is the F&P InfoSmart a disposable device or a reusable system?
The InfoSmart is a cloud‑based software platform paired with hardware interfaces; it is intended for repeated use across many patients rather than a single‑use disposable product.
What regulatory class applies to the F&P InfoSmart?
It is classified as a Class 2 medical device and was cleared via the FDA 510(k) pathway, indicating it is substantially equivalent to a legally marketed predicate device.
How is the system supplied to a clinic?
The product is provided by Fisher & Paykel Healthcare and includes the software platform plus the necessary communication accessories (telephone interface, SmartStick, or serial cable) for integration with compatible CPAP devices.