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Data / Medical devices / United States / Medline Industries, LP - SPT

Medline Industries, LP - SPT: FDA-registered device maker in Waukegan, IL, United States, 27 510(k) clearances

Medline Industries, LP - SPT is registered with the FDA (registration 1423395) in Waukegan, IL, United States. It lists 65 device types. The FDA files 27 510(k) clearances under its listings, the newest dated May 24, 2022. 8 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medline Industries, LP - SPT
FDA registration number
1423395
FEI number
3000717925
Address
1170 S Northpoint Blvd, Waukegan, IL, United States, 60085
Owner or operator
Medline Industries, LP (1417592)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
May 15, 1979
Registered through
2026
Brand names listed
140928-Suture Removal Kit CSTM, 147572-Sterile Circumcision Tray CSTM, 170019-Convenience Trays & Kits CSTM, 321236-Sterile Biospy CSTM, 946240-Skin Prep CSTM, ACCU-SORB, AKTORmed, Anesthesiology Kits and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Repackager or relabeleraccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Repackager or relabeleraccessdata.fda.gov
Arthrogram TrayOII2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Basin, EmesisFNY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)OIB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Body Fluid Disposal KitOKF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Burn Kit Without DrugOJJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cardiac Catheterization KitOES2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cardiovascular Procedure KitOEZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Care TrayOHR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Introducer KitOFD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Repackager or relabeleraccessdata.fda.gov
Central Venous Catheter Dressing Change KitPEZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Central Venous Catheter TrayOFF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cesarean Section TrayOHM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Circumcision TrayOHG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Ct Biopsy TrayOFG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dialysis Administration KitPEV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Repackager or relabeleraccessdata.fda.gov
Ear, Nose, And Throat Surgical TrayOGR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Endoscope Introducer KitNWU2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Epidural Anesthesia KitOGE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Eye TrayOJK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
General Purpose Dental TrayOFX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Gynecological Laparoscopic KitOHD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysterectomy KitOJF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
I.V. Start KitLRS2Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Label Or Tag, SterileLYV1Manufactureraccessdata.fda.gov
Labor And Delivery KitMLS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laceration TrayPKD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscopy KitFDE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nerve Block TrayOGJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Neurological TrayOJG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Obstetrical KitOKV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic TrayOJH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Patient Personal Hygiene KitNSB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pelvic Exam KitMLT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Skin Prep TrayOJU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Spinal Epidural Anesthesia KitOFT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Suture Removal KitMCZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tracheotomy Care KitNXA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Repackager or relabeleraccessdata.fda.gov
Tray, Biopsy, Without Biopsy InstrumentsFCH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, EntMMO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeleraccessdata.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
May 24, 2022K213481Medline General Surgery TrayLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 16, 2020K201129Medline Smoke Evacuation PencilGEISubstantially EquivalentMedline Industires, Inc.accessdata.fda.gov
May 6, 2019K190643Medline Electrocautery PencilGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 9, 2018K173889Medline Cautery Electrode (PTFE)GEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 19, 2017K160660Medline Waste StationDQOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 8, 2013K123095MEDLINE BLOOD PRESSURE TRANSDUCERDRSSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 17, 2012K120008MEDLINE HIGH PRESSURE INJECTION TUBINGDQOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 3, 2012K120069MEDLINE STOPCOCK AND MANIFOLDDTLSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 16, 2011K103375PLUMEPEN INTEGRATED SMOKE EVACUATION PENCILGEISubstantially EquivalentMedtek Devices, Inc.accessdata.fda.gov
December 22, 2009K093025BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODESGEISubstantially EquivalentBovie Medical Corporationaccessdata.fda.gov
October 21, 2008K081791E-Z CLEAN ELECTROSURGICAL ELECTRODEGEISubstantially EquivalentMegadyne Medical Products, Inc.accessdata.fda.gov
December 22, 2005K052865HOSPIRA CATH LAB CONVENIENCE KITSDQOSubstantially EquivalentIcu Medical, Inc.accessdata.fda.gov
February 10, 2005K040780ELECTROSURGICAL PENCILSGEISubstantially EquivalentHangzhou Shuyou Medical Instrument Company, Ltd.accessdata.fda.gov
October 18, 2004K042608TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110GEISubstantially EquivalentTecno Instruments (Pvt.) , Ltd.accessdata.fda.gov
June 18, 2003K023591ULTRA HIGH PRESSURE INJECTOR LINESDQOSubstantially EquivalentDeroyal Industries, Inc.accessdata.fda.gov
March 7, 2003K030339CAUTERY TIP CLEANER, MODEL-TC-100GEISubstantially EquivalentAspen Surgical Products, Inc.accessdata.fda.gov
August 14, 1997K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEISubstantially EquivalentTecno Instruments (Usa), Inc.accessdata.fda.gov
February 25, 1997K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
September 16, 1996K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 1, 1996K955836VALLEYLAB COATED ELECTRODESGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
September 22, 1995K954088TELESCOPING PENEVACGEISubstantially EquivalentI.C Medical, Inc.accessdata.fda.gov
September 1, 1994K943542ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODEGEISubstantially EquivalentConmedcorpaccessdata.fda.gov
June 13, 1994K936304ELECTROSURGICAL PENCILGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
February 22, 1994K932654ELECTROSURGIAL INSTRUMENTSGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 10, 1989K893814SURGICAL INSTRUMENT KIT, DISPOSABLELROSubstantially EquivalentBiosealaccessdata.fda.gov
November 10, 1981K813071E2508 DISPOSABLE HANDSWITCHING PENCILGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
July 24, 1979K791137SINGLE USE MONOPOLAR HAND CONTROL PENCILGEISubstantially EquivalentDavol, Inc.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
June 6, 202290516Class IIOngoingMedline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831Kits contain leaking bottles of isopropyl alcoholaccessdata.fda.gov
May 30, 201983000Class IIOngoingAnti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.accessdata.fda.gov
January 12, 201880197Class IITerminatedBARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.One of the cases of product might not have been sterilized.accessdata.fda.gov
April 12, 201778411Class IITerminatedArt-Line Surgery Pack-LF, STERILE, 40 packs each per case.Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In additioaccessdata.fda.gov
August 14, 201366080Class ITerminatedANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical proceduresGuidewire.035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.accessdata.fda.gov
March 30, 200635123Not yet classifiedTerminatedProxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; ManThe product may not be sterile. The pouches were damaged during sterilization.accessdata.fda.gov
March 18, 200531528Not yet classifiedTerminatedMedline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA byThe procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.accessdata.fda.gov
March 4, 200531315Not yet classifiedTerminatedMedline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.accessdata.fda.gov

Compare with other makers

Updated May 24, 2022. 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.