Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NHI — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
103 daysmedian FDA review time
130 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | 2023-01-25 | 90 | 0 |
| K221425 | Primary Relief | Dyansys, Inc. | 2022-09-13 | 120 | 0 |
| K220397 | ANSiStim-PP | Dyansys, Inc. | 2022-05-12 | 90 | 0 |
| K213188 | Primary Relief | Dyansys, Inc. | 2022-01-31 | 124 | 0 |
| K212859 | First Relief | Dyansys, Inc. | 2021-12-20 | 103 | 0 |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-10-13 | 125 | 0 |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-01-22 | 130 | 0 |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT | Spr Therapeutics, Inc. | 2018-07-31 | 61 | 0 |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad | Spr Therapeutics, LLC | 2017-06-26 | 90 | 0 |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Sti | Spr Therapeutics, LLC | 2016-07-23 | 89 | 0 |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Biowave Corporation | 2006-08-15 | 110 | 0 |
| K022241 | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE- | Vertis Neuroscience, Inc. | 2002-09-11 | 62 | 0 |
| K011702 | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS C | Vertis Neuroscience, Inc. | 2001-12-21 | 203 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda