Ibramed Equipamentos Medicos: FDA filings under this applicant name
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Ibramed Equipamentos Medicos” (first 2012, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 265 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 | 1 | 226 |
| 2013 | 1 | 175 |
| 2014 | 3 | 307 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 74 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 364 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ibramed Equipamentos Medicos took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 95 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
Most recent Ibramed Equipamentos Medicos 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242859 | VEGA | GEX | 2025-09-19 | 364 |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | IPF | 2021-05-11 | 74 |
| K131926 | THERMOPULSE | IMJ | 2014-07-24 | 393 |
| K131917 | NEURODYN COMPACT, NEURODYN II | IPF | 2014-04-29 | 307 |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | IMI | 2014-01-27 | 265 |
| K131629 | NEURODYN MULTIWAVE, AUSSIE SPORT | IPF | 2013-11-26 | 175 |
| K121369 | NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR | GZJ | 2012-12-19 | 226 |
Recalls
openFDA lists no recalls under a recalling firm named Ibramed Equipamentos Medicos.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ibramed Equipamentos Medicos (6)
- Ibramed Equipamentos Médicos (1)
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.
- Ibramed- Industria Brazileria DE Equipamentos Medi (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ibramed Equipamentos Medicos?
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Ibramed Equipamentos Medicos” (first 2012, latest 2025), across 5 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 Ibramed Equipamentos Medicos?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ibramed Equipamentos Medicos is 265 days.
Which FDA product codes appear under Ibramed Equipamentos Medicos?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); GEX (Powered Laser Surgical Instrument, 1); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1).
Next steps
- See all 7 Ibramed Equipamentos Medicos clearances with predicates and recalls
- Run predicate analysis for product code IPF, Ibramed Equipamentos Medicos'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.