ClearanceBrief
Panels › General Hospital › Product code LRS · Class 2

I.V. Start Kit

Regulation 880.5200

0510(k)s in 12 months (30 all time)
14recalls in 12 months (165 all time)
11recalls that name a 510(k)
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Top companies in LRS

DateFirm and productCodeLinked 510(k)
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Open, Classified
LRSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV
Open, Classified
LRSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Mode
Open, Classified
LRSNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
Open, Classified
LRSNone listed
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 F
Open, Classified
LRSNone listed
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CV
Open, Classified
LRSK071538
K900263 +2
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2
Open, Classified
LRSNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662
Open, Classified
LRSNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KI
Open, Classified
LRSNone listed
Apr 30, 2026Medline Industries, LP
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion)
Open, Classified
LRSNone listed
Apr 22, 2026LSL Healthcare Inc.
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Open, Classified
LRSNone listed
Apr 22, 2026ARROW INTERNATIONAL, LLC
Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protect
Open, Classified
LRSNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU
Open, Classified
LRSNone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B
Open, Classified
LRSNone listed
Jul 21, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
Open, Classified
LRSNone listed
Jun 30, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Open, Classified
LRSNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
Open, Classified
LRSNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
Open, Classified
LRSNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ;
Open, Classified
LRSNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
Open, Classified
LRSNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
Open, Classified
LRSNone listed
Mar 28, 2024Medical Action Industries, Inc. 306
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Open, Classified
LRSNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) S
Open, Classified
LRSNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED
Open, Classified
LRSNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Mode
Open, Classified
LRSNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULT
Open, Classified
LRSNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUID
Open, Classified
LRSNone listed
Feb 22, 2023Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Open, Classified
LRSNone listed
Feb 22, 2023Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Open, Classified
LRSNone listed
Feb 22, 2023Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Open, Classified
LRSNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Open, Classified
LRSNone listed
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Open, Classified
LRSNone listed
Apr 26, 2022ROi CPS LLC
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Terminated
LRSNone listed
Feb 28, 2022Resource Optimization & Innovation LLC
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Terminated
LRSNone listed
Feb 24, 2022ROi CPS LLC
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Terminated
LRSK991088
Feb 22, 2022Busse Hospital Disposables, Inc.
I.V. Start Kit Catalog 8172
Terminated
LRSNone listed
Feb 22, 2022Busse Hospital Disposables, Inc.
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Terminated
LRSNone listed
Jul 1, 2019Centurion Medical Products Corporation
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Terminated
LRSNone listed
Apr 24, 2019Centurion Medical Products Corporation
IV KIT - SORBAVIEW IVS3475
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
IV SECUREMENT KIT IVS3405
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
IV START KIT IV8440
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
INFUSA PORT KIT DYNDC1840F
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
PEDIATRIC PICC INSERTION TRAY CVI4450A
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
PEDIATRIC PICC INSERTION TRAY CVI4450
Terminated
LRSK171957
Apr 24, 2019Centurion Medical Products Corporation
PICC Line Accessory Kit CVI4285
Terminated
LRSK171957
Oct 3, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Terminated
LRSK882503

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