# K112203: Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist

- Pathway: 510(k) (Traditional)
- Applicant: Mirador Biomedical, Inc.
- Decided: Dec 14, 2011 after 135 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- 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 K831506 (1983). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101518: Compass Vascular Access; Compass Lumbar Puncture, Mirador Biomedical, Inc. (2010) Summary page 3.
- K103715: Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial Pressure, Mirador Biomedical, Inc. (2011) Summary page 2.

## Cited in the summary but kept off the family tree
- K101189: Reavillmed Pressure Monitoring System and Picc, Reavillmed (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142245: EpiAccess System (2014), 1 descendant of its own
- K133624: Compass CT, Compass CT Port (2014), 1 descendant of its own
- K170831: EpiAccess System (2017), 0 descendants of its own
- K161408: Compass Cast and MAP (2016), 0 descendants of its own

## Indications for use
The CompaSSTm GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTm Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTM Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTM Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTM Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTm Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.

Source page: https://510kreport.com/device/K112203
Methodology: https://510kreport.com/methodology