510(k) · Cleared
ClearedAckrad Hysterosalpingography Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on Sep 19, 1984 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 19, 1984
- Review
- 106 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK842231 Ackrad Hysterosalpingography SetAckrad Laboratories · 1984
- Descendant · cites it directly · 5 of its ownK940176 Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996
- Descendant · 2 generations on · 4 of its ownK970492 Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · Recalled
- Descendant · cites it directly · 3 of its ownK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK131491 Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK163318 Soules Intrauterine Insemination CatheterCook Incorporated · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K940176Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996 · cites it directly5descendants
- K970492Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · 2 generations on4descendants
- K061679Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006 · cites it directly3descendants
- K131491Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013 · 2 generations on1descendant
- K163318Soules Intrauterine Insemination CatheterCook Incorporated · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842231 | Ackrad Hysterosalpingography Set | Ackrad Laboratories | 1984 | — |
| +1 | K940176 | Ackrad Iui Set for Intrauterine Insemination | Ackrad Laboratories | 1996 | — |
| +2 | K970492 | Intrauterine Insemination and Sonohysterography Catheter | Ackrad Laboratories | 1997 | 1 |
| +1 | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| +2 | K131491 | Kitazato Iui Catheter | Kitazato Medical Co., Ltd. | 2013 | — |
| +2 | K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNA? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K940176 (Ackrad Laboratories, 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K842231 · printed Nov 5, 2026
Cite this page
510(k) Report. “K842231: Ackrad Hysterosalpingography Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842231
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026