510(k) · Cleared
ClearedTruefield Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seeing Machines Limited · HPT Perimeter, Automatic, Ac-Powered
Cleared on Aug 2, 2007 as substantially equivalent to K954167 (Carl Zeiss, Inc., 1995) after a 273-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 2, 2007
- Review
- 273 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954167 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954167 Humphrey Field Analyzer (Hfa II)Carl Zeiss, Inc. · 1995
- This deviceK063310 Truefield AnalyzerSeeing Machines Limited · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954167 | Humphrey Field Analyzer (Hfa II) | Carl Zeiss, Inc. | 1995 | — |
| 0 (this device) | K063310 | Truefield Analyzer | Seeing Machines Limited | 2007 | — |
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? (1)
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…Device 510(k) Carl Zeiss, IncHumphrey Field Analyser (HFA-1I) K954167 Device Description The TrueField Analyzer is an automated perimeter that is used to aid in measurement of visual field abnormali… | 1995 |
| † | K003442 | Modification to Edi Veris System | 2001 |
| † | K983983 | Edi Veris System | 1999 |
| † | K920937 | Computerized Pupil | 1992 |
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?
- Its one ancestor has no recall.
- 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. 2007, 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?
For the assessment of visual field abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063310: Truefield Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063310
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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