Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Moe — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
125 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884849 | BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR | Moe | 1989-03-23 | 125 | 0 |
| K884851 | BIOFEEDBACK DEVICE TG3, TG4 | Moe | 1989-02-03 | 77 | 0 |
| K884850 | BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 | Moe | 1989-02-02 | 76 | 0 |
| K884848 | BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV | Moe | 1989-02-02 | 76 | 0 |
| K884853 | BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 | Moe | 1989-02-02 | 76 | 0 |
| K884852 | BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. | Moe | 1989-02-02 | 76 | 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