510(k) · Cleared
ClearedSPRINT PNS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spr Therapeutics, Inc. · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Cleared on Oct 13, 2021 as substantially equivalent to K202660 (Spr Therapeutics, Inc., 2021) and 1 other predicate after a 125-day review. Its family tree reaches back 10 generations to 1988. 1 later device descends from it.
- Decided
- Oct 13, 2021
- Review
- 125 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 2
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 deviceK211801 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223306 SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc. · 2023
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 deviceK211801 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc. · 2023 · 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) | K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
| +1 | K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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? (2)
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…(21 CFR 882.5890) Regulatory Class: II Product Code: NHI 3. PREDICATE DEVICE Primary: SPRINT PNS System (K202660) Secondary: Biowave Deepwave System (K061166) 4. DEVICE DESCRIPTION The SPRINT PNS System is comprised of… | 2021 |
| * | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy SystemSummary page 4…y Class: II Product Code: NHI 3. PREDICATE DEVICE Primary: SPRINT PNS System (K202660) Secondary: Biowave Deepwave System (K061166) 4. DEVICE DESCRIPTION The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via… | 2006 |
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 |
|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | 2023 | 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 33 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K223306 (Spr Therapeutics, Inc., 2023) 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. 2021, 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 SPRINT PNS System is indicated for up to 60 days 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 SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211801: SPRINT PNS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211801
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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