510(k) · Cleared
ClearedPatton Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patton Medical Corp. · HIB Speculum, Vaginal, Nonmetal
Cleared on Sep 1, 1999 as substantially equivalent to K984211 (Medscand AB, 1998) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 1, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891351 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891351 Newport Lateral Vaginal RetractorSimpson/Basye, Inc. · 1989
- This deviceK991963 Patton SpeculumPatton Medical Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891351 | Newport Lateral Vaginal Retractor | Simpson/Basye, Inc. | 1989 | — |
| 0 (this device) | K991963 | Patton Speculum | Patton Medical Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K984211 | Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model…Summary page 1…e Trade Name: Patton Speculum™ Common Name: vaginal specuium Classification: nonmetal vaginal speculum Predicate Devices: Medscand Disposable Plastic Vaginal Speculum (K984211), manufactured by Medscand USA, Inc., P.O. Box 7733, Hollywood, FL 33081-1733 and the Newport Lateral Vaginal Retractor (K891351… | 1998 |
| * | K891351 | Newport Lateral Vaginal RetractorSummary page 1…nd Disposable Plastic Vaginal Speculum (K984211), manufactured by Medscand USA, Inc., P.O. Box 7733, Hollywood, FL 33081-1733 and the Newport Lateral Vaginal Retractor (K891351), manufactured by Simpson/Bayse, Inc., 430 Ayre Street, Wilmington, DE 19804. Description of Device: The Patton Speculum™ is a… | 1989 |
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 2 ancestors has a recall.
- 1 other device also cites its predicate K984211.
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 Patton SpeculunTu is intended for use to retract the
vagina in diagnostic and therapeutic obstetrical and
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/K991963 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991963: Patton Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991963
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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