510(k) Report

510(k) · Cleared

Cleared

Bioteque Vaginal Dilator

K003380510(k) TraditionalCleared Jan 29, 200190-day reviewClass II21 CFR 884.3900

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

Bioteque America, Inc. · HDX Dilator, Vaginal

Cleared on Jan 29, 2001 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 29, 2001
Review
90 days
Class
Class II
Product code
HDX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared200020052010201520202025
  1. This deviceK003380 Bioteque Vaginal DilatorBioteque America, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK071754 Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K071754Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003380Bioteque Vaginal DilatorBioteque America, Inc.2001—
+1K071754Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K003380, 2001–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HDX? 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 HDX device

  1. #1 K241748 Intimate Rose Vaginal Dilatorsscore 8.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K071754Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc.20090

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, K071754 (KARL STORZ Endoscopy-America, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HDX devices

HDX Dilator, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HDX

2in 2024

2009: 12013: 12021: 12023: 32024: 2
2007high 3 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HDX

314in 2023

2023: 314 days median
2007high 314 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HDX

No recall names HDX since 2007.

Adverse event reports per year · HDX

1in 2025

2007: 12023: 12025: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code HDX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20091—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
2023331401
20242—00
20250—01
20260—0—

More from Bioteque America, Inc.

10 FDA decisions under this applicant name. See the company

  • K041094HSG Catheter SetBioteque America, Inc. · 2004
  • K020628Curelle, Preferred Curelle, Cuteq 2.5Bioteque America, Inc. · 2002
  • K013289Bioteque Vaginal PessariesBioteque America, Inc. · 2001
  • K920633Pessary Flexible Silicone NicholsBioteque America, Inc. · 1995
  • K920747Pessary Flexible Silicone Donut RingBioteque America, Inc. · 1994

Recent decisions in HDX

The HDX category page

  • K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024
  • K233689Hope&Her Vaginal DilatorsLujena, Inc. · 2024
  • K222492Hope&Her Vaginal DilatorsLujena, Inc. · 2023
  • K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2023
  • K220035Milli Vaginal DilatorMaterna Medical · 2023

https://510kreport.com/device/K003380 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003380: Bioteque Vaginal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003380

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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