# K101189: Reavillmed Pressure Monitoring System and Picc

- Pathway: 510(k) (Traditional)
- Applicant: Reavillmed
- Decided: Dec 22, 2010 after 238 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: 3 generations back to K001901 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842352: Pressure Monitoring Kit, Utah Medical Products, Inc. (1985) Summary page 1.
- K841788: Utah Disposable Pressure Transducer, Utah Medical Products, Inc. (1985) Summary page 1.
- K031129: Poly Per-Q-Cath Picc Catheters; Poly Radpicc, C.R. Bard, Inc. (2003) Summary page 1.
- K940871: Umbili-Cath-P, Gesco Intl., Inc. (1994) Summary page 1.

## Indications for use
The ReaviHIMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.

Source page: https://510kreport.com/device/K101189
Methodology: https://510kreport.com/methodology