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Data / Medical devices / China / Jiangsu New Pentastar Medical Products Co. Ltd.

Jiangsu New Pentastar Medical Products Co. Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 30 510(k) clearances

Jiangsu New Pentastar Medical Products Co. Ltd. is registered with the FDA (registration 3015058854) in Changzhou Jiangsu, China. It lists 146 device types. The FDA files 30 510(k) clearances under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 3, 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 Jiangsu New Pentastar Medical Products Co. Ltd.
FDA registration number
3015058854
Address
Rm.1101 Blvd.#1, Tianning Shidai Plaza, Changzhou Jiangsu, China, 213000
Owner or operator
New Pentastar Medical Products Co. Limited (10063374)
Roles
Exporter to the US
First device listed
March 20, 2020
Registered through
2026
Brand names listed
ACCESSORIES, CATHETER, CATHETER HOLDER, CATHETER STRIP, ACCESSORY, SURGICAL APPAREL, ADHESIVE TAPE, BANDAGE, Skin Closure Strips, AID, TRANSFER, AIRWAY, NASOPHARYNGEAL, AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY, APPLICATOR, ABSORBENT TIPPED, STERILE; Specimen Collection Swab sterile, APRON, PROTECTIVE and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the USaccessdata.fda.gov
Accessories, CatheterKGZ1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Aid, TransferIKX1Exporter to the USaccessdata.fda.gov
Airway, NasopharyngealBTQ1Exporter to the USaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Exporter to the USaccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter to the USaccessdata.fda.gov
Apron, ProtectiveIWO1Exporter to the USaccessdata.fda.gov
Bag, ReservoirBTC1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Basin, EmesisFNY1Exporter to the USaccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
BedpanFOB1Exporter to the USaccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Exporter to the USaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the USaccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Exporter to the USaccessdata.fda.gov
CaneIPS1Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the USaccessdata.fda.gov
Catheter Care TrayOHR2Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Exporter to the USaccessdata.fda.gov
Catheter, IrrigationGBX1Exporter to the USaccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Exporter to the USaccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Exporter to the USaccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Exporter to the USaccessdata.fda.gov
Chair And Table, MedicalKMN1Exporter to the USaccessdata.fda.gov
Chair, With CastersINM1Exporter to the USaccessdata.fda.gov
Chamber, Slide CultureKIY1Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the USaccessdata.fda.gov
Closure, Wound, AdhesiveMGO1Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Container, SharpsMMK2Exporter to the USaccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Exporter to the USaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
CrutchIPR1Exporter to the USaccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Exporter to the USaccessdata.fda.gov
Device, Paste-On For Incontinence, Non-SterileNOA1Exporter to the USaccessdata.fda.gov
Device, Paste-On For Incontinence, SterileEXI1Exporter to the USaccessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, DisposableFFG2Exporter to the USaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the USaccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the USaccessdata.fda.gov
Drape, Adhesive, AerosolKGT1Exporter to the USaccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Electrode, ElectrocardiographDRX2Exporter to the USaccessdata.fda.gov
Enema KitFCE1Exporter to the USaccessdata.fda.gov
Exerciser, Non-MeasuringION1Exporter to the USaccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
General Surgery TrayLRO2Exporter to the USaccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Exporter to the USaccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Exporter to the USaccessdata.fda.gov
I.V. Start KitLRS2Exporter to the USaccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Exporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Exporter to the USaccessdata.fda.gov
Laparoscopy KitFDE2Exporter to the USaccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Exporter to the USaccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Exporter to the USaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Exporter to the USaccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Exporter to the USaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Exporter to the USaccessdata.fda.gov
Needle, CatheterGCB1Exporter to the USaccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUExporter to the USaccessdata.fda.gov
Personal Protection KitPXC1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the USaccessdata.fda.gov
Restraint, ProtectiveFMQ1Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Shield, Protective, PersonnelKPY1Exporter to the USaccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Exporter to the USaccessdata.fda.gov
Silicone Hydrogel For Scar ManagementPFP1Exporter to the USaccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Exporter to the USaccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Solvent, Adhesive TapeKOX1Exporter to the USaccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the USaccessdata.fda.gov
Stand, InfusionFOX1Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Exporter to the USaccessdata.fda.gov
Strip, Adhesive, Closure, SkinFPX1Exporter to the USaccessdata.fda.gov
Support, Patient PositionCCX1Exporter to the USaccessdata.fda.gov
Suture Removal KitMCZ1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, ManualKST1Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Exporter to the USaccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the USaccessdata.fda.gov
Tracheostomy And Nasal Suctioning KitLRQ1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the USaccessdata.fda.gov
UrinalFNP1Exporter to the USaccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Exporter to the USaccessdata.fda.gov
Walker, MechanicalITJ1Exporter to the USaccessdata.fda.gov
Wheelchair, MechanicalIOR1Exporter to the USaccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNUExporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the USaccessdata.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 22, 2026K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); GuanhongMMKSubstantially EquivalentTaizhou Huangyan Guanhong Plastic Steel Products Factoryaccessdata.fda.gov
November 19, 2025K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)FROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
July 25, 2025K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleFMFSubstantially EquivalentCMT Health PTE., Ltd.accessdata.fda.gov
April 25, 2024K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)KGNSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 7, 2024K232781Safety Sliding Blood Collection SetJKASubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
January 26, 2024K233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsLZASubstantially EquivalentAnhui Intco Medical Products Co., Ltd.accessdata.fda.gov
August 25, 2023K223600Sterilization WrapFRGSubstantially EquivalentWuhan Zonsen Medical Products Co., Ltd.accessdata.fda.gov
March 12, 2023K222456High Protection Surgical GownFYASubstantially Equivalent3A Medical Products Co., Ltd.accessdata.fda.gov
January 25, 2023K223314Disposable Blood LancetsQRKSubstantially EquivalentHuaian Hening Medical Instruments Co., Ltd.accessdata.fda.gov
September 30, 2022K222090Safety LancetFMKSubstantially EquivalentNingbo Medsun Medical Co., Ltd.accessdata.fda.gov
May 19, 2022K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)FMKSubstantially EquivalentTianjin Huahong Technology Co., Ltd.accessdata.fda.gov
January 28, 2022K212120Surgical MasksFXXSubstantially EquivalentHubei Xinxin Non-Woven Co., Ltd.accessdata.fda.gov
August 14, 2021K210381I.V. Administration SetFPASubstantially EquivalentBq Plus Medical Co., Ltd.accessdata.fda.gov
July 23, 2021K202060Disposable IV catheterFOZSubstantially EquivalentShinva Ande Healthcare Apparatus Co., Ltd.accessdata.fda.gov
September 9, 2020K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJKASubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
September 6, 2019K190213Yikang Endotracheal TubeBTRSubstantially EquivalentJiangxi Yikang Medical Instrument Group Co., Ltd.accessdata.fda.gov
January 3, 2019K180984Maxcon Sharps ContainerMMKSubstantially EquivalentNingbo Maxcon Medical Technology Co., Ltd.accessdata.fda.gov
October 29, 2018K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLLSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
August 22, 2018K173024Non-invasive blood pressure measurement systemsDXNSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
June 4, 2018K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderJKASubstantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.accessdata.fda.gov
May 25, 2018K173005SURECELL Gelling Fiber Wound DressingKGNSubstantially EquivalentJiangsu Newvalue Medical Producst Co.,Ltdaccessdata.fda.gov
January 5, 2018K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesBSPSubstantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.accessdata.fda.gov
February 16, 2017K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemNBWSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
December 4, 2015K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring SystemNBWSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
July 17, 2013K123787GREENCROSS SURGICAL MASKFXXSubstantially EquivalentJingzhou Haixin Green Cross Medical Products Co.,Laccessdata.fda.gov
December 12, 2012K121152SURGICAL GOWN, SMSFYASubstantially EquivalentJiangsu Guangda Medical Material, Co., Ltd.accessdata.fda.gov
April 18, 2012K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRIORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
February 4, 2011K093835BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWNFYASubstantially EquivalentBam Corp., Ltd.accessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 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.