# K961424: Intran 500

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Jul 10, 1996 after 89 days
- Product code: HFN (Transducer, Pressure, Intrauterine)
- Device class: 2
- Regulation: 21 CFR 884.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Intran-400: named in the summary without a submission number

## Recalls of this device
- Jun 16, 2008 · Not classified · Z-2200-2008: Possibility of compromised package sterility prior to the expiration date.

## Indications for use
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in “high risk” births.

Source page: https://510kreport.com/device/K961424
Methodology: https://510kreport.com/methodology