510(k) · Cleared
ClearedHumphrey Field Analyzer (Hfa II)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss, Inc. · HPT Perimeter, Automatic, Ac-Powered
Cleared on Nov 24, 1995 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Nov 24, 1995
- Review
- 80 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK954167 Humphrey Field Analyzer (Hfa II)Carl Zeiss, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK050350 The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview…Notal Vision, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · 3 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- Descendant · cites it directly · 3 of its ownK093213 Guided Progression Analysis on the Humphrey Field Analyzer II and II…Carl Zeiss Meditec, Inc. · 2010
- Descendant · 4 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc. · 2005 · cites it directly5descendants
- K091579Foresee HomeNotal Vision, Ltd. · 2009 · 2 generations on4descendants
- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 3 generations on3descendants
- K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc. · 2010 · cites it directly3descendants
- K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954167 | Humphrey Field Analyzer (Hfa II) | Carl Zeiss, Inc. | 1995 | — |
| +1 | K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP) | Notal Vision, Inc. | 2005 | — |
| +2 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +3 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| +1 | K093213 | Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series | Carl Zeiss Meditec, Inc. | 2010 | — |
| +4 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K050350 (Notal Vision, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HPT devicesHPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K954167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954167: Humphrey Field Analyzer (Hfa II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954167
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026