510(k) · Cleared
ClearedMedscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medscand AB · HIB Speculum, Vaginal, Nonmetal
Cleared on Dec 23, 1998 after a 29-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 23, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK984211 Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic…Medscand AB · 1998
- Descendant · cites it directly · 1 of its ownK012535 DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK041757 Femspec Disposable Vaginal SpeculumFemspec LLC · 2004
- Descendant · cites it directly · 0 of its ownK991963 Patton SpeculumPatton Medical Corp. · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984211 | Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal… | Medscand AB | 1998 | — |
| +1 | K012535 | DRG Disposable Vaginal Speculum | Doctor'S Research Group, Inc. | 2002 | — |
| +2 | K041757 | Femspec Disposable Vaginal Speculum | Femspec LLC | 2004 | — |
| +1 | K991963 | Patton Speculum | Patton Medical Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | — | Galenica disposable vaginal speculum Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K012535 (Doctor'S Research Group, Inc., 2002) has gone furthest, with 1 descendant of its own.
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 Medscand disposable speculum is intended to expose the interior of a vagina for gynecological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984211: Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984211
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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