510(k) · Cleared
ClearedIntrauterine Venogram Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 1, 2004 as substantially equivalent to K891290 (Cook Ob/Gyn, 1989) after a 161-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 1, 2004
- Review
- 161 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891290 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891290 Sholkoff Balloon Hysterosalpingography CatheterCook Ob/Gyn · 1989
- This deviceK041062 Intrauterine Venogram Needle SetCook Urological, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891290 | Sholkoff Balloon Hysterosalpingography Catheter | Cook Ob/Gyn | 1989 | — |
| 0 (this device) | K041062 | Intrauterine Venogram Needle Set | Cook Urological, Inc. | 2004 | — |
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 LKF? 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 LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K891290 | Sholkoff Balloon Hysterosalpingography CatheterSummary page 1…d technology to exist predicate devices in commercial distribution. Specifically, the Intrauterine Venogram Needle Set is similar to the Ott Intrauterine Catheter Set (K(891290) manufactured by Cook OB/GYN, and the Echotip Disposable Percutaneous Needle (Exempt) manufactured by Cook OB/GYN. Device Descr… | 1989 |
| * | — | Echotip Disposable Percutaneous Needle 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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, 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 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041062: Intrauterine Venogram Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026