510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251480Substantially Equivalent

PV01 PVDF Effort Sensor

Neurotronics, LLC, Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251480 is the FDA 510(k) clearance record for PV01 PVDF Effort Sensor, a class II device, cleared for Neurotronics, LLC on under FDA product code SFK (Respiratory Effort Belt For Polysomnography). FDA's definition for product code SFK reads: "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". FDA records list 10 510(k) clearances for Neurotronics, LLC, from to . As of , FDA records show no recalls naming K251480.

Clearance record

Decision date
Received
(108 days to decision)
Product code
SFK Respiratory Effort Belt For Polysomnography
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Neurotronics, LLC 13800 Tech City Cir., Suite 400, Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFK

Trailing 12 months

FDA records hold no clearances under product code SFK in the trailing twelve months.

FDA records show no clearances under product code SFK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260