510(k) · Cleared
ClearedPocket Colposcope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hadleigh Health Technologies, LLC · HEX Colposcope (And Colpomicroscope)
Cleared on Sep 21, 2018 as substantially equivalent to K151878 (Edan Instruments, Inc., 2015) after a 156-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Sep 21, 2018
- Review
- 156 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940094 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 2 generations backK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- 1 generation backK151878 Video ColposcopeEdan Instruments, Inc. · 2015
- This deviceK181034 Pocket Colposcope SystemHadleigh Health Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK233043 Smart Scope® CXPeriwinkle Technologies Pvt., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −2 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| −1 | K151878 | Video Colposcope | Edan Instruments, Inc. | 2015 | — |
| 0 (this device) | K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
Top candidate predicates for a new HEX device
- #1 K233043 Smart Scope® CXscore 8.4 · 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 |
|---|---|---|---|
| * | K151878 | Video ColposcopeSummary page 4…FR §884.1630 Product Code HEX, Colposcope (and colpomicroscope) Class II Predicate Device(s): K151878 – Edan Instruments, Video Colposcope, models C3A, C6A The predicate device has not been subject to a design‐related recall. Dev… | 2015 |
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 |
|---|---|---|---|
| K233043 | Smart Scope® CX | 2024 | 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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K233043 (Periwinkle Technologies Pvt., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System 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/K181034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181034: Pocket Colposcope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181034
Report an extraction error
Are you the manufacturer?
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