510(k) Report

510(k) · Cleared

Cleared

Medisul Disposable Vaginal Speculum

K000414510(k) AbbreviatedCleared Apr 4, 200056-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

Marketing Perspectives · HIB Speculum, Vaginal, Nonmetal

Cleared on Apr 4, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Apr 4, 2000
Review
56 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared200020052010201520202025
  1. This deviceK000414 Medisul Disposable Vaginal SpeculumMarketing Perspectives · 2000
  2. Descendant · cites it directly · 1 of its ownK021017 Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 2002
  3. Descendant · cites it directly · 1 of its ownK012535 DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc. · 2002
  4. Descendant · cites it directly · 0 of its ownK052420 G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006
  5. Descendant · 2 generations on · 0 of its ownK041757 Femspec Disposable Vaginal SpeculumFemspec LLC · 2004
  6. Descendant · 2 generations on · 0 of its ownK022948 Vaginal Speculum, Model 5555S, 5555M, or 5555LMedical Action Industries, Inc. · 2002

Most influential descendants

Showing 5 of 5 · See all
  • K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 2002 · cites it directly1descendant
  • K012535DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc. · 2002 · cites it directly1descendant
  • K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006 · cites it directly0descendants
  • K041757Femspec Disposable Vaginal SpeculumFemspec LLC · 2004 · 2 generations on0descendants
  • K022948Vaginal Speculum, Model 5555S, 5555M, or 5555LMedical Action Industries, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000414Medisul Disposable Vaginal SpeculumMarketing Perspectives2000—
+1K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd.2002—
+1K012535DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc.2002—
+1K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC2006—
+2K041757Femspec Disposable Vaginal SpeculumFemspec LLC2004—
+2K022948Vaginal Speculum, Model 5555S, 5555M, or 5555LMedical Action Industries, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200410
200610
FIG. 1 — Lineage of K000414, 2000–2006Source: 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 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd.20021
K012535DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc.20021
K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC20060

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, K021017 (Itl Corporation Pty, Ltd., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Marketing Perspectives

2 FDA decisions under this applicant name. See the company

  • K953669Perspectives Impregnated Hydrogel Wound DressingMarketing Perspectives · 1995

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/K000414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000414: Medisul Disposable Vaginal Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000414

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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