Dan Med, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dan Med, Inc.” (first 1997, latest 2002), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Dan Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013210 | TRUWAVE | GZJ | 2002-04-04 | 190 |
| K012885 | NEUROMOVE NM900 | IPF | 2001-11-08 | 72 |
| K010745 | EMS 3000 | IPF | 2001-06-27 | 106 |
| K991241 | IF8000 | IPF | 1999-11-02 | 204 |
| K972997 | AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION | IPF | 1997-11-10 | 90 |
| K964738 | ELPHA 2000 CONTI | KPI | 1997-08-14 | 274 |
Recalls
openFDA lists no recalls under a recalling firm named Dan Med, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dan Med, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dan Med, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Dan Med, Inc.” (first 1997, latest 2002), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dan Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dan Med, Inc. is 148 days.
Which FDA product codes appear under Dan Med, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 4); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1).
Next steps
- See all 6 Dan Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Dan Med, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.