Valmed Corp.: FDA clearances and approvals
Valmed Corp. has 5 FDA 510(k) clearances (first 1993, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time: 113 days.
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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KNN | Components, Wheelchair | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
Review panels
Most recent Valmed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031611 | P4-FITNESS | NGX | 2004-09-29 | 496 |
| K022175 | P4 PHYSIO | IPF | 2002-09-09 | 68 |
| K010754 | NURSE'S ASSISTANT O.R. CONTROL SYSTEM | GCJ | 2001-08-15 | 155 |
| K010716 | VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB | FSY | 2001-05-30 | 82 |
| K925336 | VALU-PLUS PAD | KNN | 1993-02-12 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Valmed Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Valmed Corp. have?
Valmed Corp. has 5 FDA 510(k) clearances (first 1993, latest 2004), across 5 product codes in 2 review panels.
How long does FDA take to clear Valmed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Valmed Corp.'s cleared 510(k)s is 113 days.
What devices does Valmed Corp. make?
Its most frequent FDA product codes are FSY (Light, Surgical, Ceiling Mounted, 1); GCJ (Laparoscope, General & Plastic Surgery, 1); IPF (Stimulator, Muscle, Powered, 1).
Has Valmed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Valmed Corp. Related entities may recall under other names.
Next steps
- See all 5 Valmed Corp. clearances with predicates and recalls
- Run predicate analysis for product code FSY, Valmed Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.