# K153655: Accuryn Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Potrero Medical, Inc.
- Decided: Apr 15, 2016 after 116 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003289 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070582: Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing Foley Catheters, C.R. Bard, Inc. (2007) Summary page 4.
- K070201: Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001, C.R. Bard, Inc. (2007) Summary page 4.

## Most influential descendants
- K210570: TraumaGuard Intra-abdominal Pressure Sensing System (2021), 2 descendants of its own
- K240057: TraumaGuard Intra-abdominal Pressure Sensing System (2024), 1 descendant of its own
- K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) (2026), 0 descendants of its own
- K221020: Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (2023), 0 descendants of its own

## Indications for use
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days).

Source page: https://510kreport.com/device/K153655
Methodology: https://510kreport.com/methodology