510(k) Report

510(k) · Cleared

Cleared

G-Spec Articulated Weighted Vaginal Speculum

K052420510(k) TraditionalCleared Apr 6, 2006216-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

Gynova, LLC · HIB Speculum, Vaginal, Nonmetal

Cleared on Apr 6, 2006 as substantially equivalent to K000414 (Marketing Perspectives, 2000) and 2 other predicates after a 216-day review. Its family tree reaches back 1 generation to 2000.

Decided
Apr 6, 2006
Review
216 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K000414 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestorK000414 · Medisul Disposable Vaginal Speculum · Marketing Perspectives · 200020002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors K000414 · Medisul Disposable Vaginal Speculum · Marketing Perspectives · 20000
  1. Root · 1 generation backK000414 Medisul Disposable Vaginal SpeculumMarketing Perspectives · 2000
  2. This deviceK052420 G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000414Medisul Disposable Vaginal SpeculumMarketing Perspectives2000—
0 (this device)K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
FIG. 1 — Lineage of K052420, 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), 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
Get a 510(k) Report

What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K000414Medisul Disposable Vaginal Speculum
Summary page 1
…sified Name: Nonmetal vaginal speculum 21 CFR 884.4530 5. Product Code: 85 HIB Predicate Devices: Medisul Disposable Vaginal Speculum, Marketing Perspectives, lnc.(k000414) Disposable Vaginal Speculum, Medical Action Industries, Inc. (k0022948) Kentex Disposable Vaginal Speculum, Kentron Health Care,…
Marketing Perspectives2000—
Kept off the family treeK002294FDA’s K002294 is Biocheck Testosterone Eia, Model BC-1115
Our reading of the summary gave K002294, FDA’s number for Biocheck Testosterone Eia, Model BC-1115 (Biocheck, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Disposable Vaginal Speculum, Medical Action Industries, Inc.”. Kept off the family tree.
Summary page 1
…Code: 85 HIB Predicate Devices: Medisul Disposable Vaginal Speculum, Marketing Perspectives, lnc.(k000414) Disposable Vaginal Speculum, Medical Action Industries, Inc. (k0022948) Kentex Disposable Vaginal Speculum, Kentron Health Care, k030693 Vag 0 Speculum, Panatrex, Inc. (k043950) Plastic Vaginal Specu…
Biocheck, Inc.2000—
*K030693Kentex Disposable Vaginal Speculum
Summary page 1
…m, Marketing Perspectives, lnc.(k000414) Disposable Vaginal Speculum, Medical Action Industries, Inc. (k0022948) Kentex Disposable Vaginal Speculum, Kentron Health Care, k030693 Vag 0 Speculum, Panatrex, Inc. (k043950) Plastic Vaginal Speculum, Astralite Corp. (k# unknown) Auvard Weighted Vaginal Speculum,…
Kentron Health Care, Inc.2003—
*K042950Vag O Speculum, Models VS1, VM1, VL1
Our reading of the summary gave K043950, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vag O Speculum, Panatrex, Inc.”.
Panatrex, Inc.2004—
*—Plastic Vaginal Speculum, Astralite Corp.
Named without a submission number
—
*—Auvard Weighted Vaginal Speculum, Cooper Surgical
Named without a submission number
—

Also cleared against K000414: 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?

  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K000414.

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—

What is it indicated for?

To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.

Indications for use as stated in the FDA summary.

Also cleared against K000414

2 other devices cite the same predicate.

  • K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 2002
  • K012535DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc. · 2002

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/K052420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052420: G-Spec Articulated Weighted 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/K052420

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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