510(k) Report

510(k) · Cleared

Cleared

Skytron Elite Surgical Tables

K811311510(k) TraditionalCleared Jun 2, 198122-day reviewClass II21 CFR 878.4580

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

Skytron, Div. the Kmw Group, Inc. · GBC Lamp, Surgical, Incandescent

Cleared on Jun 2, 1981 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 2, 1981
Review
22 days
Class
Class II
Product code
GBC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K811311Source: 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 GBC devices

GBC Lamp, Surgical, Incandescent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBC

FDA has decided no GBC device since 2007.

Median 510(k) review, days · GBC

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

Recalls per year · GBC

No recall names GBC since 2007.

Adverse event reports per year · GBC

No MAUDE report names GBC 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 Skytron, Div. the Kmw Group, Inc.

19 FDA decisions under this applicant name. See the company

  • K071698Aurora Led Series Surgical LightsSkytron, Div. the Kmw Group, Inc. · 20074 recalls
  • K021585Stellar Series Surgical Lights with HermesSkytron, Div. the Kmw Group, Inc. · 2002
  • K002463StellarSkytron, Div. the Kmw Group, Inc. · 2000
  • K992090Millennium GoldSkytron, Div. the Kmw Group, Inc. · 1999
  • K950192Skytron Skyboom SeriesSkytron, Div. the Kmw Group, Inc. · 19954 recalls

Recent decisions in GBC

The GBC category page

  • K896961Halux Exlite Minor Surgery LightJedmed Instrument Co. · 1990
  • K830610Flat Suction DrainSil-Med Corp. · 1983
  • K810207Minor Surgery LightCavitron Corp. · 1981

https://510kreport.com/device/K811311 · printed Nov 5, 2026

Cite this page

510(k) Report. “K811311: Skytron Elite Surgical Tables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K811311

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