510(k) · Cleared

Cleared

Humphrey Field Analyzer Model 630

K852639510(k) TraditionalCleared Sep 18, 198590-day reviewClass I21 CFR 886.1605

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zeiss Humphrey System · HPT Perimeter, Automatic, Ac-Powered

Cleared on Sep 18, 1985 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Sep 18, 1985
Review: 90 days
Class: Class I
Product code: HPT
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK852639 Humphrey Field Analyzer Model 630Zeiss Humphrey System · 1985
Descendant · cites it directly · 1 of its ownK012530 AA-1 SystemNeurovision, Inc. · 2001
Descendant · 2 generations on · 0 of its ownK023623 Novavision, Model 2.0Novavision, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K012530AA-1 SystemNeurovision, Inc. · 2001 · cites it directly1descendant
K023623Novavision, Model 2.0Novavision, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K852639	Humphrey Field Analyzer Model 630	Zeiss Humphrey System	1985	—
+1	K012530	AA-1 System	Neurovision, Inc.	2001	—
+2	K023623	Novavision, Model 2.0	Novavision, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0

FIG. 1 — Lineage of K852639, 1985–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012530	AA-1 System	Neurovision, Inc.	2001	1

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, K012530 (Neurovision, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HPT devices

HPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPT

2in 2010

2007high 2 (2010) · low 0 (2008)2026

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

2007high 1 (2018) · low 0 (2007)2025

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	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	1	—	0
2010	2	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	1
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	1
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K852639 · printed Nov 5, 2026

Cite this page

510(k) Report. “K852639: Humphrey Field Analyzer Model 630.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852639

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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