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Data / Medical devices / United States / Skytron, LLC

Skytron, LLC: FDA-registered device maker in Grand Rapids, MI, United States, 15 510(k) clearances

Skytron, LLC is registered with the FDA (registration 1825014) in Grand Rapids, MI, United States. It lists 24 device types. The FDA files 15 510(k) clearances under its listings, the newest dated March 5, 2019. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Skytron, LLC
FDA registration number
1825014
Address
5085 Corporate Exchange Blvd SE, Grand Rapids, MI, United States, 49512
Owner or operator
Skytron, LLC (9918015)
Roles
Complaint file establishment, Specification developer
First device listed
November 7, 2007
Registered through
2026
Brand names listed
"L" type anesthesia screen with two adjustable wings, without clamp, 10" foot extension without pad, 105" restraint strap (2 buckles), 12" Carbon fiber arm surgery board for 3000 & 3003 (36" & 48" extensions), 1602 X-ray top set, 18" foot extension with built in clamps and hd support rod, 18" knee rest, 2" 2PC Pad Set 3100 Welded Seam and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Exhaust, SurgicalFYD2Complaint file establishmentaccessdata.fda.gov
Armboard, WheelchairIMY1Complaint file establishmentaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Complaint file establishmentaccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Complaint file establishmentaccessdata.fda.gov
Camera, Television, Surgical, With AudioFWC1Complaint file establishmentaccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Complaint file establishmentaccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Complaint file establishmentaccessdata.fda.gov
Disinfector, Medical DevicesMEC2Complaint file establishment, Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Complaint file establishmentaccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Complaint file establishment, Specification developeraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Complaint file establishmentaccessdata.fda.gov
Light, Surgical, Floor StandingFSS2Complaint file establishmentaccessdata.fda.gov
Medical Device Data SystemOUG1Complaint file establishmentaccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
Sterilizer, SteamFLE2Complaint file establishmentaccessdata.fda.gov
Surgical Table CushionLWG1Complaint file establishment, Specification developeraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Complaint file establishment, Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishmentaccessdata.fda.gov
Table, Cystometric, ElectricMMZ2Complaint file establishmentaccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Complaint file establishment, Specification developeraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Complaint file establishmentaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Complaint file establishmentaccessdata.fda.gov
Warmer, Irrigation SolutionLHC1Complaint file establishmentaccessdata.fda.gov
Warmer, Thermal, Infusion FluidLGZ2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 5, 2019K180842MAC Medical D-Series Blanket and Solution Warming CabinetsLGZSubstantially EquivalentMac Medical, Inc.accessdata.fda.gov
April 8, 2014K133554SURGICAL LIGHT HANDLE COVERFTASubstantially EquivalentMicrotek Medical, Inc. an Ecolab Companyaccessdata.fda.gov
March 3, 2014K131402VISICLEAR SMOKE EVACUATION SYSTEMFYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
January 6, 2014K132439SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZERFLESubstantially EquivalentSakura Seiki Co., Ltd.accessdata.fda.gov
May 9, 2013K122774SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEGFLESubstantially EquivalentSakura Seiki Co., Ltd.accessdata.fda.gov
March 1, 2013K123426MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSSLLZSubstantially EquivalentOrpheus Medical , Ltd.accessdata.fda.gov
May 8, 2012K120149SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURAFLESubstantially EquivalentSakura Seiki Co., Ltd.accessdata.fda.gov
June 13, 2008K080609SWC/DWC WARMING CABINETSLHCSubstantially EquivalentMac Medicalaccessdata.fda.gov
July 6, 2007K071698AURORA LED SERIES SURGICAL LIGHTSFSYSubstantially EquivalentSkytron, Div. the Kmw Group, Inc.accessdata.fda.gov
November 8, 2000K002463STELLARFSYSubstantially EquivalentSkytron, Div. the Kmw Group, Inc.accessdata.fda.gov
June 8, 2000K000904PENADAPT 10FYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
July 7, 1995K943227BUFFALO FILTER REPLACEMENT FILTER #BSUCF03FYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
November 3, 1993K930041VICROSAFE 6 AND VICROSAFE 12FYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
September 13, 1993K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
March 20, 1990K901154MICROTEK'S SURGICAL LAMP HANDLE & COVERFTASubstantially EquivalentMicrobio-Medics, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 1, 202392290Class IIOngoingGS70 Salus Surgical Table, Product Code 18-070-70When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failuraccessdata.fda.gov
June 2, 202290400Class IIOngoingProduct Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-AUnder certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.accessdata.fda.gov
May 11, 202187939Class IIOngoingSkyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staffaccessdata.fda.gov
September 11, 202086474Class IITerminatedVGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operVGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device displayaccessdata.fda.gov
March 10, 202086439Class IITerminatedSkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.accessdata.fda.gov
March 5, 202085252Class IIOngoingSkytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.accessdata.fda.gov
April 18, 201982650Class IITerminatedSkytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure stWeld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failureaccessdata.fda.gov
April 6, 201674128Class IITerminatedEZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical TableThe potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the pataccessdata.fda.gov
March 28, 201673704Class IITerminatedErgon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen sizePotential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.accessdata.fda.gov
December 2, 201572897Class IITerminatedErgon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted raThe hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.accessdata.fda.gov
January 8, 200737120Not yet classifiedTerminatedSkytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.accessdata.fda.gov
August 4, 200535875Not yet classifiedTerminatedSkytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.accessdata.fda.gov

Compare with other makers

Updated August 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.