# K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

- Pathway: 510(k) (Traditional)
- Applicant: Macromedics BV
- Decided: May 11, 2022 after 240 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K905007 (1991). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180021: Proton Positioing and Immobilization Devices, Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap (2018) Summary page 5.
- K142420: Patient Positioning Devices, Macromedics BV (2015) Summary page 5.

## Most influential descendants
- K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (2023), 1 descendant of its own
- 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 (2025), 0 descendants of its own

## Indications for use
Both the Intended Use and the Indications for Use of the devices included in this submission are as follows: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

Source page: https://510kreport.com/device/K212909
Methodology: https://510kreport.com/methodology