510(k) · Cleared

Cleared

AA-1 System

K012530510(k) TraditionalCleared Aug 31, 200125-day reviewClass I21 CFR 886.1340

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

Cleared on Aug 31, 2001 as substantially equivalent to K852639 (Zeiss Humphrey System, 1985) and 2 other predicates after a 25-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Aug 31, 2001
Review: 25 days
Class: Class I
Product code: HJT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K841599 (1984). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK841599 Storz Universal Eye ShieldStorz Instrument Co. · 1984
This deviceK012530 AA-1 SystemNeurovision, Inc. · 2001
Descendant · cites it directly · 0 of its ownK023623 Novavision, Model 2.0Novavision, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K023623Novavision, Model 2.0Novavision, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K841599	Storz Universal Eye Shield	Storz Instrument Co.	1984	—
0 (this device)	K012530	AA-1 System	Neurovision, Inc.	2001	—
+1	K023623	Novavision, Model 2.0	Novavision, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1989	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K012530, 1984–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HJT? 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? (4)

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	Applicant	Decided	Recalls
*	K852639	Humphrey Field Analyzer Model 630 Summary page 2 …e eyes when the target slides are moved with respect to each other. The Neurovision AA-1 System is also substantially equivalent to the Humphrey Visual Field Analyzer (K852639) in that both devices collect diagnostic information through the use of software that interprets data information and reports dia…	Zeiss Humphrey System	1985	—
*	K896171	Eye Patch Summary page 2 …ing the device for further diagnosis and or treatment in the given indication for use. Lastly, the Neurovision AA-1 System is substantially equivalent to an Eye Shield (K896171) Eye Garter Company, and Eye Shield (K841599) Storz Instrument Company, that is customarily used to cover the good eye during amb…	Eye Garter Company, Inc.	1989	—
*	K841599	Storz Universal Eye Shield Summary page 2 …reatment in the given indication for use. Lastly, the Neurovision AA-1 System is substantially equivalent to an Eye Shield (K896171) Eye Garter Company, and Eye Shield (K841599) Storz Instrument Company, that is customarily used to cover the good eye during amblyopic treatment of the amblyopic eye during…	Storz Instrument Co.	1984	—
*	—	ophthalmic Haploscope Named without a submission number			—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K023623	Novavision, Model 2.0	Novavision, Inc.	2003	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K023623 (Novavision, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HJT devices

HJT Haploscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJT

FDA has decided no HJT device since 2007.

Median 510(k) review, days · HJT

Too few HJT 510(k)s in any year since 2007 to give a median.

Recalls per year · HJT

No recall names HJT since 2007.

Adverse event reports per year · HJT

1in 2024

2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code HJT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

The Vision Treatment System is indicated for the treatment of amblyopia using an interactive computerized program in patients 9 years or older suffering from amblyopia.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012530 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012530: AA-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012530

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026