# K954955: Storc Intrauterine Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Apr 17, 1996 after 173 days
- Product code: HFN (Transducer, Pressure, Intrauterine)
- Device class: 2
- Regulation: 21 CFR 884.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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) MX 4042 Series Intrauterine Pressure Catheter from Medex: named in the summary without a submission number
- (no number) Meditrace Disposable Intrauterine Catheter from Graphic Controls: named in the summary without a submission number
- (no number) Intrauterine Catheter from Telos: named in the summary without a submission number
- (no number) TUC - Intrauterine Catheter (INTRAN) from Utah Medical Products: named in the summary without a submission number

## Most influential descendants
- K052795: Philips Avalon Fetal Monitor, Models FM20 and FM30 (2005), 9 descendants of its own
- K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30 (2006), 8 descendants of its own
- K071800: Philips Avalon Fetal Monitors FM20 and FM30 (2007), 7 descendants of its own
- K100420: Philips Obtracevue Model SW Rev. G.00 (2010), 4 descendants of its own
- K092028: Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50 (2010), 3 descendants of its own

## Indications for use
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

Source page: https://510kreport.com/device/K954955
Methodology: https://510kreport.com/methodology