510(k) · Cleared
ClearedMenstrual Aspiration Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Medical Technologies, Inc. · HHI System, Abortion, Vacuum
Cleared on Apr 30, 1984 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Apr 30, 1984
- Review
- 91 days
- Class
- Class II
- Product code
- HHI
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK840383 Menstrual Aspiration KitIntl. Medical Technologies, Inc. · 1984
- Descendant · cites it directly · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- Descendant · 2 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK202445 Hystero-V HysteroscopeHysterovue, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK171113 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA…Lina Medical Aps · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · cites it directly19descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 2 generations on5descendants
- K202445Hystero-V HysteroscopeHysterovue, Inc. · 2021 · 2 generations on4descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 3 generations on4descendants
- K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840383 | Menstrual Aspiration Kit | Intl. Medical Technologies, Inc. | 1984 | — |
| +1 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| +2 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +2 | K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021 | — |
| +3 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +2 | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope… | Lina Medical Aps | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HHI? 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? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132384 | U-Scope 8000 System with HSC+Emb Cannula | 2014 | 19 |
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, K132384 (Endosec Corporation, 2014) has gone furthest, with 19 descendants of its own.
How does its category compare?
All HHI devicesHHI System, Abortion, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HHI
Too few HHI 510(k)s in any year since 2007 to give a median.
Recalls per year · HHI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHI
3in 2024
MAUDE reports naming product code HHI, 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 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K840383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840383: Menstrual Aspiration Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840383
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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