Medx Electronics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medx Electronics, Inc.” (first 2002, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | 4 | 4 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 2 | 2 |
Review panels
Most recent Medx Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082707 | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER | ILY | 2008-10-01 | 15 |
| K050022 | MEDX HOME | ILY | 2005-05-05 | 120 |
| K032231 | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER | ILY | 2003-10-03 | 74 |
| K024310 | NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY | NHN | 2003-03-24 | 90 |
| K021985 | MEDX LCS LASER SERIES | NHN | 2002-09-10 | 84 |
| K020017 | MEDX 1000 SERIES | ILY | 2002-07-12 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Medx Electronics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medx, Inc. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medx Electronics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medx Electronics, Inc.” (first 2002, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medx Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medx Electronics, Inc. is 87 days.
Which FDA product codes appear under Medx Electronics, Inc.?
The most frequent FDA product codes under this applicant name are ILY (Lamp, Infrared, Therapeutic Heating, 4); NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, 2).
Next steps
- See all 6 Medx Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILY, Medx Electronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.