Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuro Technology — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
405 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925014 | E-SP COMBINED EPI SPINAL MINISET | Neuro Technology | 1993-04-19 | 199 | 0 |
| K901810 | MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE | Neuro Technology | 1991-05-30 | 405 | 0 |
| K901811 | ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE | Neuro Technology | 1991-05-28 | 403 | 0 |
| K822139 | STIMPEN | Neuro Technology | 1982-09-13 | 56 | 0 |
| K822138 | NEUROSTIM II | Neuro Technology | 1982-07-30 | 11 | 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