Macromedics BV: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Macromedics BV” (first 2015, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 211 days. Since 2017 the median was 191 days, against 106 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 |
|---|---|---|
| 2015 | 1 | 211 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 241 |
| 2023 | 1 | 142 |
| 2024 | 0 | — |
| 2025 | 1 | 33 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Macromedics BV took a median 191 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
Review panels
- Radiology (5)
Most recent Macromedics BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | IYE | 2025-03-19 | 33 |
| K222977 | DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip | IYE | 2023-02-17 | 142 |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | IYE | 2022-06-24 | 242 |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips | IYE | 2022-05-11 | 240 |
| K142420 | Patient Positioning Devices | IYE | 2015-03-27 | 211 |
Recalls
openFDA lists no recalls under a recalling firm named Macromedics BV.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Macromedics BV?
FDA lists 5 510(k) clearances under the applicant name “Macromedics BV” (first 2015, 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 Macromedics BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Macromedics BV is 211 days. Since 2017: 191 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Macromedics BV?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 5 Macromedics BV clearances with predicates and recalls
- Run predicate analysis for product code IYE, Macromedics BV'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.