# K973746: Pre-Filled Syringe for Koala Iup

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Nov 24, 1997 after 54 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.
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) pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter: named in the summary without a submission number
- (no number) pre-filled syringes used with the Quest (formerly Healthdyne Cardiovascular) ISOFLO Intrauterine Pressure Monitoring & Amnio: named in the summary without a submission number

## Indications for use
This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.

Source page: https://510kreport.com/device/K973746
Methodology: https://510kreport.com/methodology