Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QHH — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
153 daysmedian FDA review time
225 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-10-16 | 108 | 0 |
| K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-05-15 | 86 | 0 |
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024-10-30 | 153 | 0 |
| K230526 | TEA Device | Transtimulation Research, Inc. | 2023-09-14 | 199 | 0 |
| K202940 | First Relief v1 | Dyansys, Inc. | 2020-12-29 | 90 | 0 |
| DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 | 225 | 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