Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Macromedics BV — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
242 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® base | Macromedics BV | 2025-03-19 | 33 | 0 |
| K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchS | Macromedics BV | 2023-02-17 | 142 | 0 |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | 2022-06-24 | 242 | 0 |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positi | Macromedics BV | 2022-05-11 | 240 | 0 |
| K142420 | Patient Positioning Devices | Macromedics BV | 2015-03-27 | 211 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda