510(k) · Cleared
ClearedSmart Scope® CX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Periwinkle Technologies Pvt., Ltd. · HEX Colposcope (And Colpomicroscope)
Cleared on Jun 14, 2024 as substantially equivalent to K181034 (Hadleigh Health Technologies, LLC, 2018) after a 263-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jun 14, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940094 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 3 generations backK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- 2 generations backK151878 Video ColposcopeEdan Instruments, Inc. · 2015
- 1 generation backK181034 Pocket Colposcope SystemHadleigh Health Technologies, LLC · 2018
- This deviceK233043 Smart Scope® CXPeriwinkle Technologies Pvt., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −3 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| −2 | K151878 | Video Colposcope | Edan Instruments, Inc. | 2015 | — |
| −1 | K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | 2018 | — |
| 0 (this device) | K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 HEX? 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 |
|---|---|---|---|
| * | K181034 | Pocket Colposcope SystemSummary page 6…Review Panel: Obstetrics/Gynecology Device Class: Class II Product Code: HEX Predicate Device: Pocket Colposcope System (K181034) The predicate device has not been subjected to a design-related rec… | 2018 |
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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HEX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HEX
165in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEX
No recall names HEX since 2007.
Adverse event reports per year · HEX
1in 2025
MAUDE reports naming product code HEX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 129 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 211 | 0 | 2 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 165 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the image in the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233043: Smart Scope® CX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233043
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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