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 Jan 31, 2022 as substantially equivalent to K202660 (Spr Therapeutics, Inc., 2021) after a 124-day review. Its family tree reaches back 10 generations to 1988. 1 later device descends from it.
- Decided
- Jan 31, 2022
- Review
- 124 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K881114 (1988). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations between
- 3 generations backK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 2 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 1 generation backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- This deviceK213188 Primary ReliefDyansys, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221425 Primary ReliefDyansys, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 9 generations backK970203 Epix VTEmpi · 1997
- 8 generations backK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- 7 generations backK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- 6 generations backK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- 5 generations backK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- 4 generations backK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
- 3 generations backK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 2 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 1 generation backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- This deviceK213188 Primary ReliefDyansys, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221425Primary ReliefDyansys, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −9 | K970203 | Epix VT | Empi | 1997 | — |
| −8 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| −7 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| −6 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| −5 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| −4 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
| −3 | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single… | Spr Therapeutics, LLC | 2017 | — |
| −2 | K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve… | Spr Therapeutics, Inc. | 2018 | — |
| −1 | K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
| 0 (this device) | K213188 | Primary Relief | Dyansys, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K202660 | SPRINT PNS SystemSummary page 4…vices (21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE INFORMATION Model Name: SPRINT PNS System (K202660) Manufacturer: SPR Therapeutics, Inc. Classification Name: Percutaneous Electrical Nerve Stimulation (PENS) devices… | 2021 |
| † | K173861 | Drug Relief | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221425 | Primary Relief | 2022 | 0 |
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 2.5 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K221425 (Dyansys, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202660.
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213188: Primary Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213188
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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