Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Msb , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
249 daysmedian FDA review time
612 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980229 | MSB TENS ELECTRODES (DISPOSABLE) | Msb , Ltd. | 1998-02-27 | 36 | 0 |
| K944497 | UNILECT, MONITAB AND BIOTRACE-HR | Msb , Ltd. | 1996-05-17 | 612 | 0 |
| K944496 | BIOTRACE-N, NS, 410 AND RT | Msb , Ltd. | 1996-05-16 | 611 | 0 |
| K955261 | NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTRO | Msb , Ltd. | 1996-01-30 | 82 | 0 |
| K950587 | ECOTABS | Msb , Ltd. | 1995-10-16 | 249 | 0 |
| K944260 | ECG ELECTRODE | Msb , Ltd. | 1995-07-07 | 311 | 0 |
| K944817 | NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD | Msb , Ltd. | 1994-11-09 | 41 | 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