510(k) · Decided
DecidedAckrad H/S Procedure Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · HIG Insufflator, Hysteroscopic
Cleared on Jul 15, 1988 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 15, 1988
- Review
- 87 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK881680 Ackrad H/S Procedure TrayAckrad Laboratories · 1988
- Descendant · cites it directly · 7 of its ownK020954 H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere…Ackrad Laboratories · 2002
- Descendant · 2 generations on · 5 of its ownK110288 Femvue Saline-Air DeviceFemasys, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK241693 FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK253403 FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK242002 FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K020954H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…Ackrad Laboratories · 2002 · cites it directly7descendants
- K110288Femvue Saline-Air DeviceFemasys, Inc. · 2011 · 2 generations on5descendants
- K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024 · 3 generations on1descendant
- K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025 · 4 generations on0descendants
- K242002FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881680 | Ackrad H/S Procedure Tray | Ackrad Laboratories | 1988 | — |
| +1 | K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure… | Ackrad Laboratories | 2002 | — |
| +2 | K110288 | Femvue Saline-Air Device | Femasys, Inc. | 2011 | — |
| +3 | K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024 | — |
| +4 | K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025 | — |
| +3 | K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 HIG? 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 HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &… | 2002 | 7 |
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, K020954 (Ackrad Laboratories, 2002) has gone furthest, with 7 descendants of its own.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K881680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881680: Ackrad H/S Procedure Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881680
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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