510(k) · Cleared
ClearedSmartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spr Therapeutics, LLC · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Cleared on Jul 23, 2016 as substantially equivalent to K052289 (Biowave Corporation, 2005) and 3 other predicates after an 89-day review. Its family tree reaches back 6 generations to 1988. 9 later devices descend from it.
- Decided
- Jul 23, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K881114 (1988). 20 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations backK970203 Epix VTEmpi · 1997
- 4 generations backK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- 3 generations backK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- 2 generations backK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- 1 generation backK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- This deviceK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
- Descendant · cites it directly · 7 of its ownK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK213188 Primary ReliefDyansys, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK211801 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC · 2017 · cites it directly7descendants
- K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc. · 2018 · 2 generations on6descendants
- K202660SPRINT PNS SystemSpr Therapeutics, Inc. · 2021 · 3 generations on5descendants
- K213188Primary ReliefDyansys, Inc. · 2022 · 4 generations on1descendant
- K211801SPRINT PNS SystemSpr Therapeutics, Inc. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −5 | K970203 | Epix VT | Empi | 1997 | — |
| −4 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| −3 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| −2 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| −1 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| 0 (this device) | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
| +1 | 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 | — |
| +3 | K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
| +4 | K213188 | Primary Relief | Dyansys, Inc. | 2022 | — |
| +4 | K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K052289 | Deepwave Neuromodulation Pain Therapy DeviceSummary page 4…devices (21 CFR 882.5890) Regulatory Class: II Product Codes: NHI 3. PREDICATE DEVICE BiowavePENS System (K052289, K061166, K072123, K152437) Reference devices: Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K0222… | 2005 |
| * | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy SystemSummary page 4…devices (21 CFR 882.5890) Regulatory Class: II Product Codes: NHI 3. PREDICATE DEVICE BiowavePENS System (K052289, K061166, K072123, K152437) Reference devices: Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K022241), St.… | 2006 |
| * | K072123 | Homewave Neuromodulations Pain Therapy DeviceSummary page 4…devices (21 CFR 882.5890) Regulatory Class: II Product Codes: NHI 3. PREDICATE DEVICE BiowavePENS System (K052289, K061166, K072123, K152437) Reference devices: Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K022241), St. Jude/ANS… | 2008 |
| * | K152437 | BiowaveHOME Neuromodulation Pain Therapy DeviceSummary page 4…21 CFR 882.5890) Regulatory Class: II Product Codes: NHI 3. PREDICATE DEVICE BiowavePENS System (K052289, K061166, K072123, K152437) Reference devices: Vertis Percutaneous Neuromodulation Therapy (PNT) (K011702, K022241), St. Jude/ANS Quattrode… | 2015 |
| † | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | 2001 |
| † | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX | 2002 |
| † | K991784 | Renew Lead Extension | 1999 |
| † | K000852 | Renew Neurostimulation System | 2001 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K170902 (Spr Therapeutics, LLC, 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K052289.
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. 2016, 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 Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities for:
• Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
• Symptomatic relief of post-traumatic pain;
• Symptomatic relief of post-operative pain.
The Smartpatch PNS System is not intended to treat pain in the craniofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161154
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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