510(k) · Cleared
ClearedGuided Progression Analysis on the Humphrey Field Analyzer II and II -I Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HPT Perimeter, Automatic, Ac-Powered
Cleared on Mar 12, 2010 as substantially equivalent to K954167 (Carl Zeiss, Inc., 1995) and 1 other predicate after a 150-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- Mar 12, 2010
- Review
- 150 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K012727 (2002). 7 ancestors in all, the oldest K954167 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 3 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 2 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 1 generation backK083291 Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative…Carl Zeiss Meditec, Inc. · 2009 · Recalled
- This deviceK093213 Guided Progression Analysis on the Humphrey Field Analyzer II and II…Carl Zeiss Meditec, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK130648 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2013
- Descendant · 2 generations on · 1 of its ownK141297 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 0 of its ownK200954 Glaucoma ModuleTopcon Healthcare Solutions, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −3 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −2 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −1 | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases… | Carl Zeiss Meditec, Inc. | 2009 | 2 |
| 0 (this device) | K093213 | Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series | Carl Zeiss Meditec, Inc. | 2010 | — |
| +1 | K130648 | Forum Glaucoma Workplace | Carl Zeiss Meditec, AG | 2013 | — |
| +2 | K141297 | Forum Glaucoma Workplace | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 HPT? 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? (2)
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 |
|---|---|---|---|
| * | K954167 | Humphrey Field Analyzer (Hfa II)Summary page 1…Analyzer II - i series PREDICATE DEVICES Company: Carl Zeiss Meditec, Inc. Device: Humphrey0 Field Analyzer II (K954167) Company: Carl Zeiss Meditec, Inc. Device: Cirrusm HD-OCT with Retinal Nerve Fiber Lay… | 1995 |
| * | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Summary page 1…Carl Zeiss Meditec, Inc. Device: Cirrusm HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Databases (K08329 1) KR-A3L 13 INTEND… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130648 | Forum Glaucoma Workplace | 2013 | 2 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K130648 (Carl Zeiss Meditec, AG, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K954167.
How does its category compare?
All HPT devicesHPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HPT
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HPT
Too few HPT 510(k)s in any year since 2007 to give a median.
Recalls per year · HPT
No recall names HPT since 2007.
Adverse event reports per year · HPT
1in 2023
MAUDE reports naming product code HPT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093213: Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093213
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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