510(k) · Cleared
ClearedResubmitted Artificial Insemination Instrument Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratoire Ccd C/O Washington Regulatory Services · HDR Cap, Cervical
Cleared on Jan 27, 1989 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 27, 1989
- Review
- 79 days
- Class
- Class II
- Product code
- HDR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK884696 Resubmitted Artificial Insemination Instrument SetLaboratoire Ccd C/O Washington Regulatory Services · 1989
- Descendant · cites it directly · 1 of its ownK982628 Medworks Insemination CatheterMedworks Corp. · 1998
- Descendant · 2 generations on · 0 of its ownK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
- Descendant · cites it directly · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999
Most influential descendants
Showing 3 of 3 · See all- K982628Medworks Insemination CatheterMedworks Corp. · 1998 · cites it directly1descendant
- K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002 · 2 generations on0descendants
- K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884696 | Resubmitted Artificial Insemination Instrument Set | Laboratoire Ccd C/O Washington Regulatory Services | 1989 | — |
| +1 | K982628 | Medworks Insemination Catheter | Medworks Corp. | 1998 | — |
| +2 | K021438 | Insemination Catheter, Model 320301 | Labotect Labor-Technik Gottingen | 2002 | — |
| +1 | K982630 | Medworks Visualization Insemination Catheter | Medworks Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 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 HDR? 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 HDR device
- #1 K242031 Béa Applicator (BAP-GB-01)score 9.4 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (3)
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, K982628 (Medworks Corp., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HDR devicesHDR Cap, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDR
Too few HDR 510(k)s in any year since 2007 to give a median.
Recalls per year · HDR
No recall names HDR since 2007.
Adverse event reports per year · HDR
1in 2014
MAUDE reports naming product code HDR, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K884696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884696: Resubmitted Artificial Insemination Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884696
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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