510(k) Report

510(k) · Cleared

Cleared

Pessary Flexible Silicone Nichols

K920633510(k) TraditionalCleared Nov 8, 19951,365-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. · KXP Stent, Vaginal

Cleared on Nov 8, 1995 after a 1,365-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 8, 1995
Review
1,365 days
Class
Class II
Product code
KXP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K920633Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All KXP devices

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

FDA decisions per year · KXP

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXP

Too few KXP 510(k)s in any year since 2007 to give a median.

Recalls per year · KXP

No recall names KXP since 2007.

Adverse event reports per year · KXP

1in 2008

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

MAUDE reports naming product code KXP, 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—00
20080—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20220—00
20230—00
20240—00
20250—00
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
  • K003380Bioteque Vaginal DilatorBioteque America, Inc. · 2001
  • K920747Pessary Flexible Silicone Donut RingBioteque America, Inc. · 1994

Recent decisions in KXP

The KXP category page

  • K202542Allura Vaginal StentPmt Corporation · 2020
  • K983045AmielleOwen Mumford USA, Inc. · 1998
  • K974479Silimed Vaginal StentSilimed, LLC · 1998

https://510kreport.com/device/K920633 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920633: Pessary Flexible Silicone Nichols.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920633

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026