FDA product code SFK: Respiratory Effort Belt For Polysomnography
SFK is the FDA product code for respiratory effort belt for polysomnography. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under SFK, 1 in the last five years. The average 510(k) review took 108 days (median 108); 108 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Effort Belt For Polysomnography |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for SFK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 108 |
Compare with all 510(k) review times · Search every SFK clearance
Top SFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neurotronics, LLC | 1 | 2025-08-29 |
Most recent SFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251480 | Neurotronics, LLC | PV01 PVDF Effort Sensor | 2025-08-29 | 108 |
Recalls for SFK devices
openFDA lists no recalls for product code SFK.
Frequently asked questions
What is FDA product code SFK?
SFK is the FDA product code for respiratory effort belt for polysomnography. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Anesthesiology panel.
What device class is SFK?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFK?
Across 1 cleared submissions the average was 108 days from receipt to decision (median 108).
Which companies have the most SFK clearances?
Neurotronics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFK
- Run a recall and safety report across every SFK manufacturer
- Watch product code SFK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times