510(k) · Cleared
ClearedUterine Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thomas Medical, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 25, 2002 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK022503 Uterine InjectorThomas Medical, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK092579 Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK160217 uVue HSG/SHG CatheterCook Incorporated · 2016
- Descendant · 3 generations on · 0 of its ownK181770 Intrauterine Access Balloon Catheter, Selective Salpingography…Cook Incorporated · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032835H/S Catheter SetCatheter Research, Inc. · 2003 · cites it directly7descendants
- K123258The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013 · 2 generations on3descendants
- K092579Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010 · 2 generations on2descendants
- K160217uVue HSG/SHG CatheterCook Incorporated · 2016 · 3 generations on1descendant
- K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022503 | Uterine Injector | Thomas Medical, Inc. | 2002 | — |
| +1 | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | 1 |
| +2 | K123258 | The Advance Catheter for HSG and Sis | Catheter Research, Inc. | 2013 | — |
| +2 | K092579 | Intrauterine Insemination (Iui) Catheter | Fertiligent, Ltd. | 2010 | — |
| +3 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
| +3 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032835 | H/S Catheter Set | 2003 | 7 |
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?
- Of its descendants, K032835 (Catheter Research, Inc., 2003) has gone furthest, with 7 descendants of its own.
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?
To be used during hysterosonography, hysterosalpingogram, salpingoplasties, and hydrotubation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022503: Uterine Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022503
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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