# K053016: Wireless Physiologic Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 30, 2005 after 65 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) Phoenix Disposable Pressure Transducer #73-600: named in the summary without a submission number
- (no number) SurgiChip Tag Surgical Marker: named in the summary without a submission number
- (no number) M3290A IntelliVue Information Center Software Rel. F.0 and M4840A Telemetry System II with M4841A TelePac+: named in the summary without a submission number
- (no number) MPT 24 and VitalView 24: named in the summary without a submission number

## Most influential descendants
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), 13 descendants of its own
- K090610: Hospira Vital Signs Wireless Monitoring System (2009), 9 descendants of its own
- K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver (2012), 8 descendants of its own
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), 7 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own

## Indications for use
The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Source page: https://510kreport.com/device/K053016
Methodology: https://510kreport.com/methodology