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)
Top companies in LRS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYKM1000B, Catalog Number: DYKM1000B;
2) DYKM2187A, Catalog Number: DYKM2187A Open, Classified |
LRS | None listed |
| Aug 31, 2026 | Medline 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 |
LRS | None listed |
| Aug 31, 2026 | Medline 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 |
LRS | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ARTERIAL LINE KIT, Model Number: ART890B;
2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350 Open, Classified |
LRS | None listed |
| Jun 13, 2026 | ARROW 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 |
LRS | None listed |
| Jun 13, 2026 | ARROW 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 |
LRS | K071538 K900263 +2 |
| Jun 13, 2026 | ARROW 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 |
LRS | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kit:
IV START KIT W/HUBGUARD
DYNDV2662 Open, Classified |
LRS | None listed |
| May 7, 2026 | Medline 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 |
LRS | None listed |
| Apr 30, 2026 | Medline 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 |
LRS | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131 Open, Classified |
LRS | None listed |
| Apr 22, 2026 | ARROW 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 |
LRS | None listed |
| Feb 17, 2026 | Medline 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 |
LRS | None listed |
| Jan 12, 2026 | Medline 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 |
LRS | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
IV START KIT LAB DRAW-SH, REF CDS860014P Open, Classified |
LRS | None listed |
| Jun 30, 2025 | MEDLINE 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 |
LRS | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) IV PACK SOUTH, Model Number: DYNJ88422 Open, Classified |
LRS | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit Open, Classified |
LRS | None listed |
| Sep 6, 2024 | MEDLINE 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 |
LRS | None listed |
| Aug 28, 2024 | MEDLINE 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 |
LRS | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits labeled as:
UMBILICAL VESSEL TRAY, Pack Number UVT1100 Open, Classified |
LRS | None listed |
| Mar 28, 2024 | Medical Action Industries, Inc. 306 IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile. Open, Classified |
LRS | None listed |
| Feb 25, 2024 | MEDLINE 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 |
LRS | None listed |
| Feb 25, 2024 | MEDLINE 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 |
LRS | None listed |
| Aug 3, 2023 | MEDLINE 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 |
LRS | None listed |
| Jul 20, 2023 | MEDLINE 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 |
LRS | None listed |
| Jul 20, 2023 | MEDLINE 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 |
LRS | None listed |
| Feb 22, 2023 | Cardinal Health 200, LLC Cardinal Health Presource Packs IV START KIT-Intended for IV Access
CATALOG #: 01A4553E Open, Classified |
LRS | None listed |
| Feb 22, 2023 | Cardinal Health 200, LLC Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device
CATALOG #: 01-5799A Open, Classified |
LRS | None listed |
| Feb 22, 2023 | Cardinal Health 200, LLC Cardinal Health Presource Packs IV START KIT- Intended for IV access device
CATALOG #: 01-5798B Open, Classified |
LRS | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. UNIVERSAL PLASTIC
b. KNEE ARTHROSCOPY PACK Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis 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 |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution. Open, Classified |
LRS | None listed |
| Aug 26, 2022 | Mckesson 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 |
LRS | None listed |
| Apr 26, 2022 | ROi CPS LLC Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth. Terminated |
LRS | None listed |
| Feb 28, 2022 | Resource Optimization & Innovation LLC Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site Terminated |
LRS | None listed |
| Feb 24, 2022 | ROi CPS LLC Regard Custom Procedure Kits containing BD Luer Lok Access Devices Terminated |
LRS | K991088 |
| Feb 22, 2022 | Busse Hospital Disposables, Inc. I.V. Start Kit
Catalog 8172 Terminated |
LRS | None listed |
| Feb 22, 2022 | Busse Hospital Disposables, Inc. I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics
Catalog Number: 822 Terminated |
LRS | None listed |
| Jul 1, 2019 | Centurion Medical Products Corporation NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns. Terminated |
LRS | None listed |
| Apr 24, 2019 | Centurion Medical Products Corporation IV KIT - SORBAVIEW
IVS3475 Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation IV SECUREMENT KIT
IVS3405 Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation IV START KIT
IV8440 Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation INFUSA PORT KIT
DYNDC1840F Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation PEDIATRIC PICC INSERTION TRAY
CVI4450A Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation PEDIATRIC PICC INSERTION TRAY
CVI4450 Terminated |
LRS | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation PICC Line Accessory Kit
CVI4285 Terminated |
LRS | K171957 |
| Oct 3, 2017 | Vygon 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 |
LRS | K882503 |
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