510(k) · Cleared

Cleared

Burbank Tenaculum, Model 09-0011-01

K030078510(k) TraditionalCleared Jan 24, 200315-day reviewClass II21 CFR 884.4530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vascular Control Systems, Inc. · HDC Tenaculum, Uterine

Cleared on Jan 24, 2003 as substantially equivalent to K992071 (Ron-Tech Medical, Ltd., 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Jan 24, 2003
Review: 15 days
Class: Class II
Product code: HDC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992071 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK992071 Transvaginal Ultrasound Probe Holder DeviceRon-Tech Medical, Ltd. · 1999
This deviceK030078 Burbank Tenaculum, Model 09-0011-01Vascular Control Systems, Inc. · 2003
Descendant · cites it directly · 0 of its ownK060573 Burbank TenaculumVascular Control Systems, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K060573Burbank TenaculumVascular Control Systems, Inc. · 2006 · cites it directly0descendants

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)	K030078	Burbank Tenaculum, Model 09-0011-01	Vascular Control Systems, Inc.	2003	—
+1	K060573	Burbank Tenaculum	Vascular Control Systems, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K030078, 1999–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K992071	Transvaginal Ultrasound Probe Holder Device Summary page 1 …ny: Ron-Tech Medical Ltd. Device: Transvaginal Ultrasound Probe Holder Device 5 1O@): K99207 1 Date Cleared: August 27, 1999 B. Company: Gilbert Surgical Instrument…	Ron-Tech Medical, Ltd.	1999	—
*	—	Sims Uterine Sound Named without a submission number			—

Also cleared against K992071: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060573	Burbank Tenaculum	Vascular Control Systems, Inc.	2006	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?

Its one ancestor has no recall.
Of its descendants, K060573 (Vascular Control Systems, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K992071.

How does its category compare?

All HDC devices

HDC Tenaculum, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HDC

1in 2023

2007high 2 (2007) · low 0 (2009)2026

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

2007high 6 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HDC

5in 2022

2007high 5 (2022) · low 0 (2007)2025

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 Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030078: Burbank Tenaculum, Model 09-0011-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030078

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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