510(k) · Cleared
ClearedPV01 PVDF Effort Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotronics, LLC · SFK Respiratory Effort Belt For Polysomnography
Cleared on Aug 29, 2025 as substantially equivalent to K173868 (Neurotronics, Inc., 2018) after a 108-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Aug 29, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- SFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K915494 (1993). 16 ancestors in all, the oldest K862527 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 7 generations backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- 6 generations backK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- 5 generations backK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- 4 generations backK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- 3 generations backK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- 2 generations backK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
- 1 generation backK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018
- This deviceK251480 PV01 PVDF Effort SensorNeurotronics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| −7 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| −6 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −5 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| −4 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| −3 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| −2 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| −1 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018 | — |
| 0 (this device) | K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SFK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173868 | Serenity Body Position Sensor, Serenity RIP SensorsSummary page 5…tion: II Review Panel: Neurology Predicate/Reference Devices Predicate Device Reference Device Submission Number: K173868 K040605 Device Name: RIP01 RIP Sensor DYMEDIX Reusable Respiratory Eff… | 2018 |
| † | K040605 | Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All SFK devicesSFK Respiratory Effort Belt For Polysomnography: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFK
Too few SFK 510(k)s in any year since 2007 to give a median.
Recalls per year · SFK
No recall names SFK since 2007.
Adverse event reports per year · SFK
No MAUDE report names SFK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251480: PV01 PVDF Effort Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251480
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026