510(k) · Cleared

Cleared

Microvision Scleral Buckling Components

K023481510(k) TraditionalCleared Jan 8, 200383-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

Microvision, Inc. · HQX Implant, Orbital, Extra-Ocular

Cleared on Jan 8, 2003 as substantially equivalent to K950806 (Mira, Inc., 1996) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1978.

Decided: Jan 8, 2003
Review: 83 days
Class: Class II
Product code: HQX
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K780987 (1978). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK780987 Soft Silicone Elastomer Sponge ExplantMedical Instrument Research Assoc., Inc. · 1978
1 generation backK950806 Solid Dilicone Implants, Sdilicone Sponge ImplantsMira, Inc. · 1996
This deviceK023481 Microvision Scleral Buckling ComponentsMicrovision, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K780987	Soft Silicone Elastomer Sponge Explant	Medical Instrument Research Assoc., Inc.	1978	—
−1	K950806	Solid Dilicone Implants, Sdilicone Sponge Implants	Mira, Inc.	1996	—
0 (this device)	K023481	Microvision Scleral Buckling Components	Microvision, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1988	1	0
1995	1	0

FIG. 1 — Lineage of K023481, 1978–2003Source: 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 HQX? 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
*	K950806	Solid Dilicone Implants, Sdilicone Sponge Implants Summary page 1 …l equivalence to the solid silicone and silicone sponge implants cleared for marketing under the following 5 1O(k)s: 0 Mira, Inc. (K950806) 0 Storz Ophthalmics, Inc. (K832481, K950599) 0 Labtician Ophthalmics, Inc. (K875014) 4. INTEN…	Mira, Inc.	1996	—
*	K832481	Scleral Buckling Implants Dif/Types Summary page 1 …sponge implants cleared for marketing under the following 5 1O(k)s: 0 Mira, Inc. (K950806) 0 Storz Ophthalmics, Inc. (K832481, K950599) 0 Labtician Ophthalmics, Inc. (K875014) 4. INTENDED USE The MicroVision Scleral Buckling Compone…	Storz Instrument Co.	1983	—
*	K950599	Stors Scleral Sponge II (Lincoff Design) Summary page 1 …plants cleared for marketing under the following 5 1O(k)s: 0 Mira, Inc. (K950806) 0 Storz Ophthalmics, Inc. (K832481, K950599) 0 Labtician Ophthalmics, Inc. (K875014) 4. INTENDED USE The MicroVision Scleral Buckling Components are s…	Storz Ophthalmics, Inc.	1995	—
*	K875014	Labtician Retinal Implants Summary page 1 …O(k)s: 0 Mira, Inc. (K950806) 0 Storz Ophthalmics, Inc. (K832481, K950599) 0 Labtician Ophthalmics, Inc. (K875014) 4. INTENDED USE The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants int…	Labtician Products, Inc.	1988	—

Also cleared against K950806: 1 other device →

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?

The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K950806.

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	—	—

What is it indicated for?

The MicroVision Scleral Buckling Components are solid silicone and silicone:sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023481: Microvision Scleral Buckling Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023481

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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