510(k) · Cleared
ClearedTransvaginal Ultrasound Probe Holder Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ron-Tech Medical, Ltd. · HDC Tenaculum, Uterine
Cleared on Aug 27, 1999 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 27, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK992071 Transvaginal Ultrasound Probe Holder DeviceRon-Tech Medical, Ltd. · 1999
- Descendant · cites it directly · 1 of its ownK030078 Burbank Tenaculum, Model 09-0011-01Vascular Control Systems, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK060573 Burbank TenaculumVascular Control Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK032585 Transvaginal Ultrasound Probe Holder SystemRon-Tech Medical, Ltd. · 2004
Most influential descendants
Showing 3 of 3 · See all- K030078Burbank Tenaculum, Model 09-0011-01Vascular Control Systems, Inc. · 2003 · cites it directly1descendant
- K060573Burbank TenaculumVascular Control Systems, Inc. · 2006 · 2 generations on0descendants
- K032585Transvaginal Ultrasound Probe Holder SystemRon-Tech Medical, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992071 | Transvaginal Ultrasound Probe Holder Device | Ron-Tech Medical, Ltd. | 1999 | — |
| +1 | K030078 | Burbank Tenaculum, Model 09-0011-01 | Vascular Control Systems, Inc. | 2003 | — |
| +2 | K060573 | Burbank Tenaculum | Vascular Control Systems, Inc. | 2006 | — |
| +1 | K032585 | Transvaginal Ultrasound Probe Holder System | Ron-Tech Medical, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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, K030078 (Vascular Control Systems, Inc., 2003) has gone furthest, with 1 descendant 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.
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 Transvaginal Ultrasound Probe Holder device is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992071: Transvaginal Ultrasound Probe Holder Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992071
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