Imds Operations B.V.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Imds Operations B.V.” (first 2012, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 195 days. Since 2017 the median was 178 days, against 105 days for all cleared 510(k)s in the same product codes. 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 | 256 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 218 |
| 2021 | 2 | 112 |
| 2022 | 0 | — |
| 2023 | 1 | 212 |
| 2024 | 1 | 90 |
| 2025 | 1 | 253 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Imds Operations B.V. took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 8 | 8 |
Review panels
- Cardiovascular (8)
Most recent Imds Operations B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | DQY | 2025-04-17 | 253 |
| K241611 | ShapeIT (SI014135) | DQY | 2024-09-03 | 90 |
| K223728 | Micro Rx | DQY | 2023-07-13 | 212 |
| K210431 | ReCross | DQY | 2021-07-15 | 153 |
| K210110 | Guidion | DQY | 2021-03-31 | 71 |
| K200324 | NHancer Rx | DQY | 2020-08-06 | 178 |
| K191229 | TrapIt | DQY | 2020-01-21 | 258 |
| K121077 | NHANCER | DQY | 2012-12-21 | 256 |
Recalls
openFDA lists no recalls under a recalling firm named Imds Operations B.V..
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.
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.
- Imds (Innovative MEdical Device Systems) - Leis ME (1 510(k)s)
- IMDS Operation B.V. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imds Operations B.V.?
FDA lists 8 510(k) clearances under the applicant name “Imds Operations B.V.” (first 2012, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imds Operations B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imds Operations B.V. is 195 days. Since 2017: 178 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Imds Operations B.V.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 8).
Next steps
- See all 8 Imds Operations B.V. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Imds Operations B.V.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.