Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medx Electronics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
190 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082707 | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABL | Medx Electronics, Inc. | 2008-10-01 | 15 | 0 |
| K050022 | MEDX HOME | Medx Electronics, Inc. | 2005-05-05 | 120 | 0 |
| K032231 | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, | Medx Electronics, Inc. | 2003-10-03 | 74 | 0 |
| K024310 | NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY | Medx Electronics, Inc. | 2003-03-24 | 90 | 0 |
| K021985 | MEDX LCS LASER SERIES | Medx Electronics, Inc. | 2002-09-10 | 84 | 0 |
| K020017 | MEDX 1000 SERIES | Medx Electronics, Inc. | 2002-07-12 | 190 | 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