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Skytron Infinity Series Surgical Lights

by Skytron, Div. the Kmw Group, Inc.

510(k) K915285

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915285 Date20 Feb 1992ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-0529-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0527-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0530-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0534-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0525-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0528-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0531-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0524-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0532-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0526-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285
    • Terminated Z-0533-2007 FDA Unclassified (pre-2012) initiated 8 Jan 2007 on shared 510(k) K915285

    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FSY
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A surgical light, ceiling mounted, used for illumination during surgical procedures. It is a device classified under product code FSY and regulation number 878.4580.

The device received FDA 510(k) clearance (K915285) on February 20, 1992, as substantially equivalent to a predicate device. It is manufactured by Skytron, Div. the Kmw Group, Inc., located in Grand Rapids, MI, and is intended for use in general and plastic surgery settings.

Other devices from Skytron, Div. the Kmw Group, Inc.

See all devices from Skytron, Div. the Kmw Group, Inc. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Skytron Infinity Series Surgical Light used for?

    It is used for illumination during surgical procedures, specifically intended for use in general and plastic surgery settings to provide adequate lighting for visualization of the operative field.

  • How is the Skytron Infinity Series Surgical Light supplied or installed?

    It is a ceiling-mounted device, meaning it is designed to be fixed to the ceiling of an operating room, providing stable and adjustable illumination without occupying floor or boom space.

  • Is the Skytron Infinity Series Surgical Light reusable or single-use?

    It is a reusable device, as it is a fixed ceiling-mounted surgical light intended for repeated use over time with proper cleaning and maintenance between procedures.

  • What regulatory pathway was used for the Skytron Infinity Series Surgical Light?

    It received FDA 510(k) clearance (K915285) on February 20, 1992, demonstrating substantial equivalence to a legally marketed predicate device under the traditional 510(k) pathway.