# K251480: PV01 PVDF Effort Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, LLC
- Decided: Aug 29, 2025 after 108 days
- Product code: SFK (Respiratory Effort Belt For Polysomnography)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K915494 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors, Neurotronics, Inc. (2018) Summary page 5.

## Indications for use
The PVDF Effort Sensor is intended to measure and output respiratory effort signals from a patient for archival in a sleep study. The sensor is an accessory to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The PVDF Effort Sensor is intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside of a medical facility under the direction of a medical professional. The PVDF Effort Sensor does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, • an alarm or alarm system; • an apnea monitor or apnea monitoring system; or • life monitor or life monitoring system.

Source page: https://510kreport.com/device/K251480
Methodology: https://510kreport.com/methodology