510(k) · Cleared
ClearedGynex Endospeculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynex Corp. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on Apr 8, 1998 after a 75-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 8, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KNA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | Kogan Endospeculum Named without a submission number |
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.
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the wurethra and cervix.
Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
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/K980237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980237: Gynex Endospeculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980237
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026