510(k) · Cleared
ClearedPre-Filled Syringe for Koala Iup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, Inc. · HFN Transducer, Pressure, Intrauterine
Cleared on Nov 24, 1997 after a 54-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 24, 1997
- Review
- 54 days
- Class
- Class II
- Product code
- HFN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HFN device
- #1 K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)score 9.4 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter Named without a submission number | |
| * | — | pre-filled syringes used with the Quest (formerly Healthdyne Cardiovascular) ISOFLO… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HFN devicesHFN Transducer, Pressure, Intrauterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HFN
Too few HFN 510(k)s in any year since 2007 to give a median.
Recalls per year · HFN
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFN
4in 2024
MAUDE reports naming product code HFN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This accessory is used with a Koala Intrauterine Pressure System and is
used in priming the catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973746: Pre-Filled Syringe for Koala Iup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973746
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026