Osteometer Meditech A/S: FDA clearances and approvals
Osteometer Meditech A/S has 2 FDA 510(k) clearances (first 1997, latest 1997), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 290 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 2 | 2 |
| MUA | Bone Sonometer | 1 | 0 |
Review panels
- Radiology (3)
Most recent Osteometer Meditech A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964562 | DTX-200 BONE DENSITOMETER | KGI | 1997-08-22 | 282 |
| K963789 | DTX-100 BONE DENSITOMETER | KGI | 1997-07-14 | 297 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980010 | PMA | DTU-ONE ULTRASOUND SCANNER | 2000-09-19 |
Recalls
openFDA lists no recalls under a recalling firm named Osteometer Meditech A/S.
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 Osteometer Meditech A/S have?
Osteometer Meditech A/S has 2 FDA 510(k) clearances (first 1997, latest 1997), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Osteometer Meditech A/S's 510(k)s?
The median time from FDA receipt to decision across Osteometer Meditech A/S's cleared 510(k)s is 290 days.
What devices does Osteometer Meditech A/S make?
Its most frequent FDA product codes are KGI (Densitometer, Bone, 2); MUA (Bone Sonometer, 1).
Has Osteometer Meditech A/S had device recalls?
openFDA lists no recalls under a recalling firm name matching Osteometer Meditech A/S. Related entities may recall under other names.
Next steps
- See all 2 Osteometer Meditech A/S clearances with predicates and recalls
- Run predicate analysis for product code KGI, Osteometer Meditech A/S'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.