510(k) · Cleared
ClearedLeespec Disposable Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itl Corporation Pty, Ltd. · HIB Speculum, Vaginal, Nonmetal
Cleared on Jun 19, 2002 as substantially equivalent to K000414 (Marketing Perspectives, 2000) after an 82-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jun 19, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000414 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000414 Medisul Disposable Vaginal SpeculumMarketing Perspectives · 2000
- This deviceK021017 Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK022948 Vaginal Speculum, Model 5555S, 5555M, or 5555LMedical Action Industries, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022948Vaginal Speculum, Model 5555S, 5555M, or 5555LMedical Action Industries, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000414 | Medisul Disposable Vaginal Speculum | Marketing Perspectives | 2000 | — |
| 0 (this device) | K021017 | Leespec Disposable Vaginal Speculum | Itl Corporation Pty, Ltd. | 2002 | — |
| +1 | K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555L | Medical Action Industries, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000414 | Medisul Disposable Vaginal SpeculumSummary page 1…. The LeeSpecTM Disposable Vaginal Speculum has the same technological characteristics as and is substantially equivalent to the Medisul disposable Vaginal Speculum (K000414), as shown in the following table: r. , . ~, v", ,."7""~.d . Feature… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555L | 2002 | 0 |
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?
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIB
2in 2014
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIB
3in 2025
MAUDE reports naming product code HIB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The LeeSpecTMDisposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021017: Leespec 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/K021017
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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