510(k) · Cleared
ClearedAckrad Iui Set for Intrauterine Insemination
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · MFD Cannula, Intrauterine Insemination
Cleared on Apr 23, 1996 as substantially equivalent to K842231 (Ackrad Laboratories, 1984) after an 833-day review. Its family tree reaches back 1 generation to 1984. 5 later devices descend from it.
- Decided
- Apr 23, 1996
- Review
- 833 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K842231 (1984). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK842231 Ackrad Hysterosalpingography SetAckrad Laboratories · 1984
- This deviceK940176 Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996
- Descendant · cites it directly · 4 of its ownK970492 Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · Recalled
- Descendant · 2 generations on · 3 of its ownK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK131491 Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK163318 Soules Intrauterine Insemination CatheterCook Incorporated · 2017
- Descendant · 4 generations on · 0 of its ownK162667 Kitazato IUI CatheterKitazato Corporation · 2017
Most influential descendants
Showing 5 of 5 · See all- K970492Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · cites it directly4descendants
- K061679Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006 · 2 generations on3descendants
- K131491Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013 · 3 generations on1descendant
- K163318Soules Intrauterine Insemination CatheterCook Incorporated · 2017 · 3 generations on0descendants
- K162667Kitazato IUI CatheterKitazato Corporation · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842231 | Ackrad Hysterosalpingography Set | Ackrad Laboratories | 1984 | — |
| 0 (this device) | K940176 | Ackrad Iui Set for Intrauterine Insemination | Ackrad Laboratories | 1996 | — |
| +1 | K970492 | Intrauterine Insemination and Sonohysterography Catheter | Ackrad Laboratories | 1997 | 1 |
| +2 | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| +3 | K131491 | Kitazato Iui Catheter | Kitazato Medical Co., Ltd. | 2013 | — |
| +3 | K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017 | — |
| +4 | K162667 | Kitazato IUI Catheter | Kitazato Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 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 MFD? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K894837 | Royal Women’s Coaxial Catheter Set Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…mination Predicate devices a. Royal Women’s Coaxial Catheter Set model no. KJLLS-852100 and 852101 marketed by Cook OB/GYN of Spencer, Indiana (Exhibit 2). 510(K) No. K894837. b. Ackrad H/S Catheter Set (K842231) (Exhibit 3) Description of the device The Ackrad IUI Set consists of two parts: a calibrat… | |
| * | K842231 | Ackrad Hysterosalpingography SetSummary page 1…Women’s Coaxial Catheter Set model no. KJLLS-852100 and 852101 marketed by Cook OB/GYN of Spencer, Indiana (Exhibit 2). 510(K) No. K894837. b. Ackrad H/S Catheter Set (K842231) (Exhibit 3) Description of the device The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing cathete… | 1984 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970492 | Intrauterine Insemination and Sonohysterography Catheter | 1997 | 4 |
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?
How does its category compare?
All MFD devicesMFD Cannula, Intrauterine Insemination: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MFD
FDA has decided no MFD device since 2007.
Median 510(k) review, days · MFD
Too few MFD 510(k)s in any year since 2007 to give a median.
Recalls per year · MFD
No recall names MFD since 2007.
Adverse event reports per year · MFD
1in 2022
MAUDE reports naming product code MFD, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way. The patient population comprises women generally ranging in age from 25 to 45.
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/K940176 · printed Nov 5, 2026
Cite this page
510(k) Report. “K940176: Ackrad Iui Set for Intrauterine Insemination.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K940176
Report an extraction error
Are you the manufacturer?
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