510(k) · Cleared
Recalled · Class II · 2014H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Apr 16, 2002 as substantially equivalent to K953034 (Ackrad Laboratories, 1995) after a 22-day review. Its family tree reaches back 1 generation to 1995. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 16, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953034 (1995). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- This deviceK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 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 · cites it directly · 3 of its ownK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- 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
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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
- K061679Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006 · cites it directly3descendants
- K092579Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010 · 2 generations on2descendants
- K160217uVue HSG/SHG CatheterCook Incorporated · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| 0 (this device) | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 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 | — |
| +1 | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| +2 | K092579 | Intrauterine Insemination (Iui) Catheter | Fertiligent, Ltd. | 2010 | — |
| +3 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Summary page 1…ingography or Hysterosonography Catheter Common Name: Classification Name: Cannula, manipulator/injector, Uterine, Product Code LKF Modified Hysterosalpingography Set K953034, 8/29/95 March 13, 2002 Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories, Inc.… | 1995 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2014 | Class II | Z-2570-2014 | Packaging process control | Unsealed pouches. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
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/K020951 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020951
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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