# K142420: Patient Positioning Devices

- Pathway: 510(k) (Traditional)
- Applicant: Macromedics BV
- Decided: Mar 27, 2015 after 211 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: 5 generations back to K905007 (1991). 17 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060737: Sinmed Positioning Devices, Sinmed BV (2006) Summary page 5.
- K111340: Head and Neck Immobilization System, Body Immobilization System, Medtec, Inc. (2011) Summary page 11.
- K080072: Mri Patient Positioning Devices, CIVCO Medical Instruments Co., Inc. (2008) Summary page 13.

## Most influential descendants
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (2022), 2 descendants of its own
- K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (2023), 1 descendant of its own
- K210894: Siddharth-II; Impact (2021), 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
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

Source page: https://510kreport.com/device/K142420
Methodology: https://510kreport.com/methodology