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Well Lead Medical Co. Ltd: FDA-registered device maker in GUANGZHOU Guangdong, China, 16 510(k) clearances

Well Lead Medical Co. Ltd is registered with the FDA (registration 3010400865) in GUANGZHOU Guangdong, China. It lists 42 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 5, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Well Lead Medical Co. Ltd
FDA registration number
3010400865
Address
No. 47 Guomao Avenue South Panyu, GUANGZHOU Guangdong, China, 511434
Owner or operator
WELL LEAD MEDICAL CO. LTD (9045441)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer
First device listed
September 10, 2003
Registered through
2027
Brand names listed
ARGYLE SILICONE SALEM SUMP TUBE, Aerosol Mask, All Silicone Foley Catheter with Temperature Sensor, ClearPetra Suction-Evacuation Sheath, Cricothyrotomy kit, DRAIN PENROSE, DYNASEAL Dynamic Supraglottic Airway, Deluxe Drainage Bags and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Manufactureraccessdata.fda.gov
Biopsy Needle Guide KitOIJ2Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Manufactureraccessdata.fda.gov
Catheter, PeritonealGBW1Manufactureraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, StraightEZD2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Suprapubic (And Accessories)KOB2Contract manufactureraccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Catheter, UrethralGBM2Manufactureraccessdata.fda.gov
Catheter, UrologicalKOD2Contract manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Manufactureraccessdata.fda.gov
Cricothyrotomy KitOGP2Manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufactureraccessdata.fda.gov
Device, Cystometric, HydraulicFEN2Manufactureraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Manufactureraccessdata.fda.gov
Dilator, UrethralKOE2Manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscope Channel AccessoryODC2Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Kit, NephroscopeFGA2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract manufacturer, Manufactureraccessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or IntubationFEG2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Contract manufacturer, Manufactureraccessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)CBI2Contract manufacturer, Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Contract manufacturer, Manufactureraccessdata.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, 2025K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactGBMSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
May 22, 2023K220722PVC Hydrophilic Urethral CatheterEZDSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
July 21, 2022K211543Wei Nasal Jet TubeBTRSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
January 14, 2022K211814Wellead Endoscopic SealODCSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
April 8, 2021K202134Well Lead All Silicone Foley Catheter with Temperature SensorEZLSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
December 9, 2020K203119ClearPetra Suction-Evacuation SheathFEDSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
December 11, 2019K182739Endotracheal Tube with Evacuation LumenBTRSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
October 11, 2017K162340Stomach TubeKNTSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
November 29, 2016K160801Well Lead Extraction BagGCJSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
October 12, 2016K161110ClearPetra Suction-Evacuation SheathFEDSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
October 28, 2014K142563Well Lead PVC Urethral CatheterEZDSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
August 26, 2011K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALBTRSubstantially EquivalentWell Lead Medical Co., Ltd.accessdata.fda.gov
March 11, 2010K092886WELL LEAD ENDOBRONCHIAL TUBESCBISubstantially EquivalentWell Lead Instrumentsaccessdata.fda.gov
October 8, 2008K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZLSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
July 10, 2008K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEBTRSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
February 18, 2005K042683WELL LEAD ENDOTRACHEAL TUBEBTRSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
July 31, 202699685Class IIOngoingSunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25The 6Fr suction catheter could not pass through the samples smoothly.accessdata.fda.gov

Compare with other makers

Updated September 15, 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.