# K101518: Compass Vascular Access; Compass Lumbar Puncture

- Pathway: 510(k) (Traditional)
- Applicant: Mirador Biomedical, Inc.
- Decided: Oct 13, 2010 after 133 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: 4 generations back to K831506 (1983). 7 ancestors in all.
6 later devices descend from it; 3 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)
- K091408: Disposable Pressure Transducer, Shenzhen Ant Hi-Tech Industrial Co., Ltd. (2009) Summary page 2.
- K043065: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1P, Edwards Lifesciences, LLC (2005) Summary page 2.
- K844214: Compartment Syndrome Pressure Monitor Sys, Stryker Corp. (1985) Summary page 2.

## Most influential descendants
- K112203: Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist (2011), 4 descendants of its own
- K142245: EpiAccess System (2014), 1 descendant of its own
- K133624: Compass CT, Compass CT Port (2014), 1 descendant of its own
- K254074: TruPress (2026), 0 descendants of its own
- K170831: EpiAccess System (2017), 0 descendants of its own

## Indications for use
The Comnpass TM Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure. The CompaSSTm Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.

Source page: https://510kreport.com/device/K101518
Methodology: https://510kreport.com/methodology