510(k) Report

FDA applicant

Skytron, Div. the Kmw Group, Inc.

Grand Rapids, MI19 decisions1981–200719 recalls

FDA records 19 decisions for Skytron, Div. the Kmw Group, Inc. (Grand Rapids, MI) from 1981 to 2007: 19 510(k) clearances. Most are in product codes FSY (Light, Surgical, Ceiling Mounted) and GDC (Table, Operating-Room, Electrical). Its devices cite 1 predicate, 1 of them its own earlier devices. 19 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Skytron, Div. the Kmw Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2024

2007: 112016: 12020: 12024: 4
2007high 11 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Skytron, Div. the Kmw Group, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FSYLight, Surgical, Ceiling Mounted6decisions
  • GDCTable, Operating-Room, Electrical4decisions
  • JEATable, Surgical With Orthopedic Accessories, Ac-Powered1decision
  • HBNChair, Neurosurgical1decision
  • FQOTable, Operating-Room, Ac-Powered1decision
  • KZFDevice, Medical Examination, Ac Powered1decision

Also: FWY (1), FWW (1), GBC (1), FNM (1), INX (1).

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071698Aurora Led Series Surgical LightsSkytron, Div. the Kmw Group, Inc. · 20072cite it
  • K002463StellarSkytron, Div. the Kmw Group, Inc. · 20001cites it

What has FDA decided for it lately?

  • 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
  • K940616Skytron Elite 3500 TableSkytron, Div. the Kmw Group, Inc. · 1994
  • K933564Skytron Exam LightSkytron, Div. the Kmw Group, Inc. · 1994
  • K926045Skytron Life Island 21Skytron, Div. the Kmw Group, Inc. · 1993

All 19 as Skytron, Div. the Kmw Group, Inc. →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K071698Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series…Jul 9, 2024Class II
  • K071698Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora…Jul 9, 2024Class II
  • K071698Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora…Jul 9, 2024Class II
  • K071698Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora…Jul 9, 2024Class II
  • K950192Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount…Mar 5, 2020Class II
  • K950192Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single…Mar 28, 2016Class II