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Data / Medical devices / United States / ASP Global, LLC

ASP Global, LLC: FDA-registered device maker in Austell, GA, United States, 2 510(k) clearances

ASP Global, LLC is registered with the FDA (registration 3004824601) in Austell, GA, United States. It lists 60 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 12, 1998. 3 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 ASP Global, LLC
FDA registration number
3004824601
Address
7800 Third Flag Pkwy, Austell, GA, United States, 30168
Owner or operator
ASP Global, LLC (9066528)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
March 6, 2009
Registered through
2026
Brand names listed
Ram Scientific, Safe-T-Fill

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Specification developeraccessdata.fda.gov
Accessories, WheelchairKNO1Complaint file establishment, Specification developeraccessdata.fda.gov
Adaptor, DressingILD1Specification developeraccessdata.fda.gov
Adaptor, HygieneILS1Complaint file establishment, Specification developeraccessdata.fda.gov
Adaptor, RecreationalILT1Specification developeraccessdata.fda.gov
Aid, TransferIKX1Complaint file establishment, Specification developeraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Specification developeraccessdata.fda.gov
Armboard, WheelchairIMY1Specification developeraccessdata.fda.gov
Bandage, CastITG1Complaint file establishment, Specification developeraccessdata.fda.gov
Basin, EmesisFNY1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Board, Arm (With Cover), Non-SterileNOD1Specification developeraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
CaneIPS1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Chair And Table, MedicalKMN1Specification developeraccessdata.fda.gov
Clip, NoseBXJ1Specification developeraccessdata.fda.gov
Components, ExerciseIOD1Specification developeraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Specification developeraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Specification developeraccessdata.fda.gov
Cover, LimbIPM1Specification developeraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
CrutchIPR1Specification developeraccessdata.fda.gov
Cutter, SurgicalFZT1Specification developeraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Specification developeraccessdata.fda.gov
Dressing, CompressionMHW1Complaint file establishment, Specification developeraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Complaint file establishment, Specification developeraccessdata.fda.gov
EsthesiometerGXB1Specification developeraccessdata.fda.gov
Exerciser, Non-MeasuringION1Complaint file establishment, Specification developeraccessdata.fda.gov
FileHTP1Specification developeraccessdata.fda.gov
Helmet, Cranial, For Protective UseNDA1Specification developeraccessdata.fda.gov
Hematocrit, Tube, Rack, Sealer, HolderGHY2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Holder, Crutch And Cane, WheelchairIMZ1Specification developeraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Specification developeraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthosis, CervicalIQK1Specification developeraccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Specification developeraccessdata.fda.gov
Orthosis, Limb BraceIQI1Specification developeraccessdata.fda.gov
Pack, Heat, MoistIMA1Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Pill Crusher/CutterOHY1Specification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Specification developeraccessdata.fda.gov
Sling, ArmILI1Specification developeraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Complaint file establishment, Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
Staple, Removable (Skin)GDT1Specification developeraccessdata.fda.gov
Support, ArmIOY1Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishment, Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Complaint file establishment, Specification developeraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Specification developeraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Complaint file establishment, Specification developeraccessdata.fda.gov
Tourniquet, PneumaticKCY1Complaint file establishment, Specification developeraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Complaint file establishment, Specification developeraccessdata.fda.gov
Utensil, EatingILC1Specification developeraccessdata.fda.gov
Utensil, HomemakingIKW1Specification developeraccessdata.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
November 12, 1998K983517SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMJKASubstantially EquivalentRam Scientificaccessdata.fda.gov
September 3, 1998K981973SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMJKASubstantially EquivalentRam Scientificaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
August 24, 202699676Class IIOngoingBrand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is useDue to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.accessdata.fda.gov
September 26, 202597592Class IIOngoingSAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used tDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.accessdata.fda.gov
May 5, 202597551Class IIOngoingSAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, ModeAll RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.accessdata.fda.gov

Compare with other makers

Updated October 1, 2026. 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.