Data / Medical devices / United States / LSL Healthcare
LSL Healthcare: FDA-registered device maker in Niles, IL, United States, 16 510(k) clearances
LSL Healthcare is registered with the FDA (registration 1420054) in Niles, IL, United States. It lists 84 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 15, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1420054
- Address
- 6200 W Howard St, Niles, IL, United States, 60714
- Owner or operator
- LSL Healthcare (1420054)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- March 9, 1983
- Registered through
- 2026
- Brand names listed
- ACCESSORY, SURGICAL APPAREL, BASIN, EMESIS, BEDPAN, BOUGIE, UROLOGICAL, BRUSH, SCRUB, OPERATING-ROOM, Bath, Sitz, Nonpowered, Bed Patient Monitor, CATHETERS, SUCTION, TRACHEOBRONCHIAL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Ureteral Catheter | EYI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Arthrogram Tray | OII | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bath, Sitz, Nonpowered | KTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bedpan | FOB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Body Fluid Clean Up Kit | OKG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Body Fluids Barrier Kit | OKH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bougie, Urological | FAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Cleaning, Tracheal Tube | EPE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter Care Tray | OHR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Peritoneal | GBW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Circumcision Tray | OHG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dressing Change Tray | OXQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Repackager or relabeler | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Iodine (Tincture) | IAL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nerve Block Tray | OGJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orotracheal Intubation Guide Kit | OGK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Patient Personal Hygiene Kit | NSB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Peripheral Catheter Insertion Kit | OWL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Skin Prep Tray | OJU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture Kit | OVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture Removal Kit | MCZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Transport, Aerobic | JTW | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tracheostomy Kit | OGW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Urinal | FNP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Utensil, Eating | ILC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing Kit | MCY | 2 | Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| June 15, 2016 | K153496 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Rayxin Medical Products Co., Ltd. | accessdata.fda.gov |
| December 18, 2014 | K140228 | DISPOSABLE TRACHEAL TUBE | BTR | Substantially Equivalent | Suzhou Weikang Medical Apparatus Co., Ltd. | accessdata.fda.gov |
| October 15, 2013 | K130231 | NON-CONTACT INFRARED THERMOMETER | FLL | Substantially Equivalent | Jinxinbao Electronic Co.,Ltd | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
| July 19, 2012 | K120970 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) | LZA | Substantially Equivalent | Tangshan Zhonghong Pulin Plastic Co.,Ltd | accessdata.fda.gov |
| July 17, 2012 | K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | JHI | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| December 13, 2010 | K102718 | DIGITAL THERMOMETER; DIGITAL THERMOMETER | FLL | Substantially Equivalent | International Regulatory Consultants, LLC (Irc) | accessdata.fda.gov |
| August 3, 2010 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
| September 24, 2007 | K070432 | GENERAL SURGERY DRAPES | KKX | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| July 24, 2007 | K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| April 18, 2005 | K050122 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) | LZA | Substantially Equivalent | Smart Glove Corp. Sdn Bhd | accessdata.fda.gov |
| April 3, 2002 | K020592 | ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 | DWL | Substantially Equivalent | Alba-Waldensian, Inc. | accessdata.fda.gov |
| June 2, 2000 | K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | BSP | Substantially Equivalent | Myco Medical Supplies, Inc. | accessdata.fda.gov |
| January 26, 1995 | K945225 | DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES | FMF | Substantially Equivalent | Myco Medical Supplies, Inc. | accessdata.fda.gov |
| April 4, 1979 | K790366 | URINE CULTURE KIT | JTW | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| March 9, 2026 | 98631 | Class II | Ongoing | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. | accessdata.fda.gov |
| December 22, 2025 | 98245 | Class II | Ongoing | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit | BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. | accessdata.fda.gov |
Compare with other makers
Updated April 22, 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.