# Macromedics BV

- Location (FDA's records): Moordrecht, NL
- FDA decisions: 5 (2015–2025): 5 510(k) clearances
- Product codes: IYE (5)
- 510(k) review time since 2016: median 191 days, against 171 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sinmed BV: 1 (https://510kreport.com/company/sinmed)
- Medtec, Inc.: 1 (https://510kreport.com/company/medtec)
- CIVCO Medical Instruments Co., Inc.: 1 (https://510kreport.com/company/civco-medical-instruments)
- Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap: 1 (https://510kreport.com/company/medtec-dba-civco-medical-solutions-and-civco-radiotherap)
- Medtec, Inc. Dba Civco Medical Solutions and Civco: 1 (https://510kreport.com/company/medtec-dba-civco-medical-solutions-and-civco)

## Firms that cite its devices most
- Panacea Medical Technologies Pvt., Ltd.: 1 (https://510kreport.com/company/panacea-medical-technologies-pvt)
- Qfix: 1 (https://510kreport.com/company/qfix)

## Its most-cited devices
- K142420: Patient Positioning Devices (2015), cited by 5
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (2022), cited by 1
- K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (2023), cited by 1

## Recent decisions
- 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 (Mar 19, 2025)
- K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (Feb 17, 2023)
- K213439: FlexBoardTM, EagleBoardTM, BreastBoard SXTM (Jun 24, 2022)
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (May 11, 2022)
- K142420: Patient Positioning Devices (Mar 27, 2015)

Source page: https://510kreport.com/company/macromedics