510(k) · Cleared

Cleared

Storz MVS 19 & 20 Gauge Scleral Plugs

K854507510(k) TraditionalCleared Feb 7, 198687-day reviewClass II21 CFR 886.4155

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

Storz Instrument Co. · LXP Plug, Scleral

Cleared on Feb 7, 1986 after an 87-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: Feb 7, 1986
Review: 87 days
Class: Class II
Product code: LXP
Recalls: None
Predicates: 0

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

This deviceK854507 Storz MVS 19 & 20 Gauge Scleral PlugsStorz Instrument Co. · 1986
Descendant · cites it directly · 0 of its ownK022186 Scleral Plugs, 19 and 20 GaugeMicrovision, Inc. · 2003
Descendant · cites it directly · 0 of its ownK990872 Scleral Plugs, 19 and 20 GaugeOphthalmic Consultants, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K022186Scleral Plugs, 19 and 20 GaugeMicrovision, Inc. · 2003 · cites it directly0descendants
K990872Scleral Plugs, 19 and 20 GaugeOphthalmic Consultants, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K854507	Storz MVS 19 & 20 Gauge Scleral Plugs	Storz Instrument Co.	1986	—
+1	K022186	Scleral Plugs, 19 and 20 Gauge	Microvision, Inc.	2003	—
+1	K990872	Scleral Plugs, 19 and 20 Gauge	Ophthalmic Consultants, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0

FIG. 1 — Lineage of K854507, 1986–2003Source: 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 LXP? 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

Get a 510(k) Report

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)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022186	Scleral Plugs, 19 and 20 Gauge	Microvision, Inc.	2003	0
K990872	Scleral Plugs, 19 and 20 Gauge	Ophthalmic Consultants, Inc.	1999	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, K022186 (Microvision, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LXP devices

LXP Plug, Scleral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXP

FDA has decided no LXP device since 2007.

Median 510(k) review, days · LXP

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

Recalls per year · LXP

No recall names LXP since 2007.

Adverse event reports per year · LXP

No MAUDE report names LXP since 2007.

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	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K854507 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854507: Storz MVS 19 & 20 Gauge Scleral Plugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854507

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026