# K073053: Colpo-Master

- Pathway: 510(k) (Traditional)
- Applicant: United Products & Instruments, Inc.
- Decided: Nov 15, 2007 after 16 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853389 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853389: Wallach Zoom Colposcope, Wallach Surgical Devices, Inc. (1985) Summary page 1.
- K031639: Intermed Zoom Colposcope, Intermed Group, Inc. (2003) Summary page 1.
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K073053
Methodology: https://510kreport.com/methodology