Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NUW — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
203 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243290 | BTL-785MJ | BTL Industries, Inc. | 2025-05-09 | 203 | 0 |
| K203525 | D function | Ito Co., Ltd. | 2021-05-05 | 155 | 0 |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Myotronics-Noromed, Inc. | 2004-07-20 | 154 | 0 |
| K031998 | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | 2003-07-24 | 27 | 0 |
| K901902 | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Microcurrent Research, Inc. | 1990-10-09 | 165 | 0 |
| K890143 | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | Microcurrent Research, Inc. | 1989-05-01 | 108 | 0 |
| K842224 | BNS 40 | Myo-Tronics Research, Inc. | 1984-11-19 | 167 | 0 |
| K842223 | J4 MYO-MONITOR | Myo-Tronics Research, Inc. | 1984-11-19 | 167 | 0 |
| K770252 | MONITOR, MYO, MODEL J3 | Myo-Tronics Research, Inc. | 1977-02-18 | 9 | 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