510(k) Report

510(k) · Cleared

Cleared

Disposable Scleral Globe Plug

K840693510(k) TraditionalCleared May 22, 198496-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

Innovative Surgical Products, Inc. · LXP Plug, Scleral

Cleared on May 22, 1984 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 22, 1984
Review
96 days
Class
Class II
Product code
LXP
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K840693Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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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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?

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.

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Innovative Surgical Products, Inc.

12 FDA decisions under this applicant name. See the company

  • K843041Heslin Dispos. Tubing SetInnovative Surgical Products, Inc. · 1984
  • K840695Phacoemulsification KitsInnovative Surgical Products, Inc. · 1984
  • K840694Lens Insertion GlideInnovative Surgical Products, Inc. · 1984
  • K841072Irrigation, Aspiration Tubing SetsInnovative Surgical Products, Inc. · 1984
  • K832235Disposable Vitrectomy HandpieceInnovative Surgical Products, Inc. · 1983

Recent decisions in LXP

The LXP category page

  • K022186Scleral Plugs, 19 and 20 GaugeMicrovision, Inc. · 2003
  • K990872Scleral Plugs, 19 and 20 GaugeOphthalmic Consultants, Inc. · 1999
  • K945114Visitec Scleral PlugVisitec Co. · 1995
  • K925671Disposable Scleral PlugsO.R. Specialties, Inc. · 1993
  • K880952Prisma Disposable 19 and 20 Gauge Scleral PlugsAdvanced Surgical Products, Inc. · 1988

https://510kreport.com/device/K840693 · printed Nov 4, 2026

Cite this page

510(k) Report. “K840693: Disposable Scleral Globe Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K840693

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026