510(k) · Cleared
ClearedASPIVIX v1.1 Cervical Suction Tenaculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspivix SA · HDC Tenaculum, Uterine
Cleared on Aug 17, 2021 as substantially equivalent to K073182 (Gyn-Disposables, Inc., 2007) after a 231-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Aug 17, 2021
- Review
- 231 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890379 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK890379 Uterine TentaculumKinetic Medical Products · 1989
- 2 generations backK980247 Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998
- 1 generation backK073182 Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 2007 · Recalled
- This deviceK203820 ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA · 2021
- Descendant · cites it directly · 0 of its ownK223866 Carevix™ Suction Cervical StabilizerAspivix SA · 2023
Most influential descendants
Showing 1 of 1 · See all- K223866Carevix™ Suction Cervical StabilizerAspivix SA · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890379 | Uterine Tentaculum | Kinetic Medical Products | 1989 | — |
| −2 | K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | Gynex Corp. | 1998 | — |
| −1 | K073182 | Gyn Disposables Tenaculum 356T | Gyn-Disposables, Inc. | 2007 | 7 |
| 0 (this device) | K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021 | — |
| +1 | K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 HDC? 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 HDC device
- #1 K223866 Carevix™ Suction Cervical Stabilizerscore 5.6 · 4 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073182 | Gyn Disposables Tenaculum 356TSummary page 5…Class II Regulation Name & 21 CFR 884.4530 - Obstetric-gynecologic specialized manual Number: instrument Predicate Device: K073182 - GYN Disposables INC Tenaculum 356T The predicate device has not been subject to a design-related reca… | 2007 |
| † | K142204 | Bioceptive Suction Cervical Retractor | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223866 | Carevix™ Suction Cervical Stabilizer | 2023 | 0 |
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K223866 (Aspivix SA, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HDC devicesHDC Tenaculum, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HDC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HDC
Too few HDC 510(k)s in any year since 2007 to give a median.
Recalls per year · HDC
6in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDC
5in 2022
MAUDE reports naming product code HDC, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 6 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203820: ASPIVIX v1.1 Cervical Suction Tenaculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203820
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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