510(k) Report

510(k) · Cleared

Cleared

Kolplux System

K110766510(k) TraditionalCleared Sep 15, 2011181-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

Kolplast CI Ltda · HIB Speculum, Vaginal, Nonmetal

Cleared on Sep 15, 2011 as substantially equivalent to K070964 (Welch Allyn, Inc., 2007) after a 181-day review. Its family tree reaches back 2 generations to 1994.

Decided
Sep 15, 2011
Review
181 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K941272 (1994). No later device cites it as a predicate yet.

K941272 · Kleenspec · Welch Allyn, Inc. · 1994K070964 · Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System · Welch Allyn, Inc. · 200719901995200020052010
K070964 · Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System · Welch Allyn, Inc. · 2007K941272 · Kleenspec · Welch Allyn, Inc. · 19940
  1. Root · 2 generations backK941272 KleenspecWelch Allyn, Inc. · 1994
  2. 1 generation backK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
  3. This deviceK110766 Kolplux SystemKolplast CI Ltda · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K941272KleenspecWelch Allyn, Inc.1994—
−1K070964Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination…Welch Allyn, Inc.2007—
0 (this device)K110766Kolplux SystemKolplast CI Ltda2011—
FIG. 1 — Lineage of K110766, 1994–2011Source: 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), 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 HIB? 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 HIB device

  1. #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K070964Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System
Summary page 1
…t Device Company Product 510(k) # Welch Allyn Inc. Kleenspec Single Use Vaginal Speculum & K070964 790 Series Cordless Illumination System DEVICE DESCRIPTION 807.92(a)(4)…
Welch Allyn, Inc.2007—

Also cleared against K070964: 2 other devices →

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?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
  • None of the 2 ancestors has a recall.
  • 2 other devices also cite its predicate K070964.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HIB

2in 2014

2007: 12008: 22009: 12010: 12011: 12012: 12013: 12014: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIB

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

Recalls per year · HIB

1in 2015

2015: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · HIB

3in 2025

2007: 12008: 22009: 12010: 102011: 152012: 152013: 92014: 82015: 52016: 22017: 52018: 32019: 42020: 42021: 42022: 22023: 32024: 22025: 3
2007high 15 (2011) · low 1 (2007)2025

MAUDE reports naming product code HIB, 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
20071—01
20082—02
20091—01
20101—010
20111—015
20121—015
20131—09
20142—08
20150—15
20160—02
20170—05
20180—03
20190—04
20200—04
20210—04
20220—02
20230—03
20240—02
20250—03
20261—1—

What is it indicated for?

The KOLPLUX System when used with a vaginal speculum provides illumination during

pelvic examination and other gynecological procedures, such as pap smears, dilation

and curettage (D&C), biopsy, and electrosurgery.

Indications for use as stated in the FDA summary.

Also cleared against K070964

2 other devices cite the same predicate.

  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall
  • K072762Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008

Recent decisions in HIB

The HIB category page

  • K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
  • K132668Iob Disposable SpeculumIob Medical, Inc. · 2014
  • K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall

https://510kreport.com/device/K110766 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110766: Kolplux System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110766

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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