# K093213: Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Mar 12, 2010 after 150 days
- Product code: HPT (Perimeter, Automatic, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1605
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K012727 (2002). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954167: Humphrey Field Analyzer (Hfa II), Carl Zeiss, Inc. (1995) Summary page 1.
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000, Carl Zeiss Meditec, Inc. (2009) Summary page 1.

## Most influential descendants
- K130648: Forum Glaucoma Workplace (2013), 2 descendants of its own
- K141297: Forum Glaucoma Workplace (2014), 1 descendant of its own
- K200954: Glaucoma Module (2020), 0 descendants of its own

## Indications for use
The Carl Zeiss Medlitec, Inc. Guided Progression Analysis is a software analysis module for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II-i series (HFA II-i) that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma.

Source page: https://510kreport.com/device/K093213
Methodology: https://510kreport.com/methodology