Waismed, Ltd.: FDA clearances and approvals
Waismed, Ltd. has 7 FDA 510(k) clearances (first 1998, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time: 85 days. openFDA lists 3 product recalls by a recalling firm named Waismed, Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 28 |
| 2015 | 0 | — |
| 2016 | 1 | 92 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 217 |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Waismed, Ltd.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Waismed, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211968 | NIO+ Adult | FMI | 2021-07-22 | 28 |
| K190538 | NIO-I | FMI | 2019-10-07 | 217 |
| K160805 | NIO-P | FMI | 2016-06-23 | 92 |
| K142086 | NIO -INTRAOSSEOUS DEVICE | FMI | 2014-08-28 | 28 |
| K062940 | BONE INJECTION GUN (B.I.G.) | FMI | 2006-12-22 | 85 |
| K022415 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST | FMI | 2002-10-11 | 79 |
| K981853 | BONE INJECTION GUN (B.I.G.) DEVICE | FMI | 1998-11-17 | 175 |
Recalls
3 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-06-05.
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 Waismed, Ltd. have?
Waismed, Ltd. has 7 FDA 510(k) clearances (first 1998, latest 2021), across 1 product code in 1 review panel.
How long does FDA take to clear Waismed, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Waismed, Ltd.'s cleared 510(k)s is 85 days.
What devices does Waismed, Ltd. make?
Its most frequent FDA product codes are FMI (Needle, Hypodermic, Single Lumen, 7).
Has Waismed, Ltd. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Waismed, Ltd; the most recent began 2025-06-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Waismed, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Waismed, Ltd.'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.