510(k) · Cleared
ClearedPrimary Relief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Cleared on Sep 13, 2022 as substantially equivalent to K213188 (Dyansys, Inc., 2022) after a 120-day review. Its family tree reaches back 11 generations to 1988.
- Decided
- Sep 13, 2022
- Review
- 120 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K881114 (1988). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK881114 Empi Model 989, TensEmpi · 1988
- 7 generations between
- 3 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 2 generations backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- 1 generation backK213188 Primary ReliefDyansys, Inc. · 2022
- This deviceK221425 Primary ReliefDyansys, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK881114 Empi Model 989, TensEmpi · 1988
- 10 generations backK970203 Epix VTEmpi · 1997
- 9 generations backK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- 8 generations backK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- 7 generations backK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- 6 generations backK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- 5 generations backK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
- 4 generations backK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 3 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 2 generations backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- 1 generation backK213188 Primary ReliefDyansys, Inc. · 2022
- This deviceK221425 Primary ReliefDyansys, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −10 | K970203 | Epix VT | Empi | 1997 | — |
| −9 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| −8 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| −7 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| −6 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| −5 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
| −4 | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single… | Spr Therapeutics, LLC | 2017 | — |
| −3 | K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve… | Spr Therapeutics, Inc. | 2018 | — |
| −2 | K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
| −1 | K213188 | Primary Relief | Dyansys, Inc. | 2022 | — |
| 0 (this device) | K221425 | Primary Relief | Dyansys, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 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 NHI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHI device
- #1 K202660 SPRINT PNS Systemscore 12.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K213188 | Primary ReliefSummary page 4…NS) devices (21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE INFORMATION Model Name: Primary Relief (K213188) Manufacturer: DyAnsys, Inc. Classification Name: Percutaneous Electrical Nerve Stimulation (PENS) devices (… | 2022 |
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 34 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- None of the 25 ancestors has a recall.
How does its category compare?
All NHI devicesNHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NHI
120in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHI
No recall names NHI since 2007.
Adverse event reports per year · NHI
13in 2025
MAUDE reports naming product code NHI, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 3 | 125 | 0 | 6 |
| 2022 | 3 | 120 | 0 | 8 |
| 2023 | 1 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221425: Primary Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221425
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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