510(k) · Cleared
ClearedKahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Cleared on Apr 21, 2014 after a 26-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 21, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- HES
- 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 HES? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | V. Mueller Preamendment Uterine Cannulas 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 HES devicesHES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HES
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HES
Too few HES 510(k)s in any year since 2007 to give a median.
Recalls per year · HES
No recall names HES since 2007.
Adverse event reports per year · HES
1in 2025
MAUDE reports naming product code HES, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 68 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140761: Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140761
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026