510(k) · Cleared

Cleared

Scleral Buckling Implants Dif/Types

K832481510(k) TraditionalCleared Sep 20, 198356-day reviewClass II21 CFR 886.3340

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

Storz Instrument Co. · HQX Implant, Orbital, Extra-Ocular

Cleared on Sep 20, 1983 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Sep 20, 1983
Review: 56 days
Class: Class II
Product code: HQX
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK832481 Scleral Buckling Implants Dif/TypesStorz Instrument Co. · 1983
Descendant · cites it directly · 0 of its ownK023481 Microvision Scleral Buckling ComponentsMicrovision, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K023481Microvision Scleral Buckling ComponentsMicrovision, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K832481	Scleral Buckling Implants Dif/Types	Storz Instrument Co.	1983	—
+1	K023481	Microvision Scleral Buckling Components	Microvision, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K832481, 1983–2003Source: 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.

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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? (1)

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

Number	Device	Applicant	Decided	Descendants
K023481	Microvision Scleral Buckling Components	Microvision, 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?

Of its descendants, K023481 (Microvision, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HQX devices

HQX Implant, Orbital, Extra-Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQX

FDA has decided no HQX device since 2007.

Median 510(k) review, days · HQX

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

Recalls per year · HQX

No recall names HQX since 2007.

Adverse event reports per year · HQX

2in 2022

2007high 5 (2018) · low 0 (2007)2025

MAUDE reports naming product code HQX, 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	—	2
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	5
2019	—	2
2020	—	0
2021	—	0
2022	—	2
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K832481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K832481: Scleral Buckling Implants Dif/Types.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832481

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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