DeviceClearance

Product code SFK— Neurology

PV01 PVDF Effort Sensor

Classification name
Respiratory Effort Belt For Polysomnography
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.”

— U.S. Food and Drug Administration, device classification record for product code SFK under 21 CFR 882.1400, via openFDA

Market context for product code SFK

FDA has cleared 1 device under product code SFK, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SFK

Recent clearances under product code SFK

Data sourced from openFDA. This site is unofficial and independent of the FDA.