510(k) · Cleared

Cleared

Colpo-Master

K073053510(k) TraditionalCleared Nov 15, 200716-day reviewClass II21 CFR 884.1630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

United Products & Instruments, Inc. · HEX Colposcope (And Colpomicroscope)

Cleared on Nov 15, 2007 as substantially equivalent to K853389 (Wallach Surgical Devices, Inc., 1985) and 2 other predicates after a 16-day review. Its family tree reaches back 2 generations to 1985.

Decided: Nov 15, 2007
Review: 16 days
Class: Class II
Product code: HEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K853389 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK853389 Wallach Zoom ColposcopeWallach Surgical Devices, Inc. · 1985
1 generation backK031639 Intermed Zoom ColposcopeIntermed Group, Inc. · 2003
This deviceK073053 Colpo-MasterUnited Products & Instruments, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K853389	Wallach Zoom Colposcope	Wallach Surgical Devices, Inc.	1985	—
−1	K031639	Intermed Zoom Colposcope	Intermed Group, Inc.	2003	—
0 (this device)	K073053	Colpo-Master	United Products & Instruments, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1996	1	0

FIG. 1 — Lineage of K073053, 1985–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K853389	Wallach Zoom Colposcope Summary page 1 …21, 2007 (2) Name of Device Trade Name: Colpo-Master Common Name: Colposcope Classification name: Colposcope (3) Equivalent legally-marketed devices. 1. Wallach Zoom K853389 2. Intermed Zoom K031639 3. Welch-Allyn K955635 (4) Description Kl%% N NOV 15 2007 (2 Kordosd peg 24> The…	Wallach Surgical Devices, Inc.	1985	—
*	K031639	Intermed Zoom Colposcope Summary page 1 …ce Trade Name: Colpo-Master Common Name: Colposcope Classification name: Colposcope (3) Equivalent legally-marketed devices. 1. Wallach Zoom K853389 2. Intermed Zoom K031639 3. Welch-Allyn K955635 (4) Description Kl%% N NOV 15 2007 (2 Kordosd peg 24> The Colposcope consists of thr…	Intermed Group, Inc.	2003	—
*	K955635	Video Colposcope/Vertical Rolling Base/Swing Arm Stand Summary page 1 …aster Common Name: Colposcope Classification name: Colposcope (3) Equivalent legally-marketed devices. 1. Wallach Zoom K853389 2. Intermed Zoom K031639 3. Welch-Allyn K955635 (4) Description Kl%% N NOV 15 2007 (2 Kordosd peg 24> The Colposcope consists of three main assemblies: Mic…	Welch Allyn, Inc.	1996	—

Also cleared against K853389: 3 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
None of the 5 ancestors has a recall.
3 other devices also cite its predicate K853389.

How does its category compare?

All HEX devices

HEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HEX

1in 2024

2007high 3 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HEX

165in 2016

2007high 211 (2014) · low 129 (2010)2026

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

2007high 2 (2008) · low 0 (2007)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	MAUDE reports
2007	2	—	0
2008	1	—	2
2009	0	—	0
2010	3	129	0
2011	2	—	1
2012	0	—	0
2013	2	—	0
2014	3	211	2
2015	1	—	0
2016	3	165	0
2017	1	—	0
2018	2	—	0
2019	1	—	2
2020	0	—	1
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	1	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

The UNICO Colpo-Master Colposcope is indicated for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy

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/K073053 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073053: Colpo-Master.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073053

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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