510(k) · Cleared
ClearedTransvaginal Ultrasound Probe Holder System
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 Jan 9, 2004 as substantially equivalent to K992071 (Ron-Tech Medical, Ltd., 1999) after a 141-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 9, 2004
- Review
- 141 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992071 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992071 Transvaginal Ultrasound Probe Holder DeviceRon-Tech Medical, Ltd. · 1999
- This deviceK032585 Transvaginal Ultrasound Probe Holder SystemRon-Tech Medical, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992071 | Transvaginal Ultrasound Probe Holder Device | Ron-Tech Medical, Ltd. | 1999 | — |
| 0 (this device) | K032585 | Transvaginal Ultrasound Probe Holder System | Ron-Tech Medical, Ltd. | 2004 | — |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K992071 | Transvaginal Ultrasound Probe Holder DeviceSummary page 1…n ultrasound transducer Classification: HDC/ITX Predicate Device: Transvaginal Ultrasound Probe Holder device, Ron-Tech Medical Ltd. Israel, cleared under 5 10(k) no. K992071 Description of the device: The SafeTChoiceT rm Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K992071.
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 SafeTChoiceTM Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoiceTM Transvaginal Ultrasound Probe Holder System 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 as stated in the FDA summary.
https://510kreport.com/device/K032585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032585: Transvaginal Ultrasound Probe Holder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032585
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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