FDA Review Panel · HO

FDA 510(k) General Hospital Devices

FDA 510(k) General Hospital Devices - Regulatory Overview

FDA 510(k) general hospital devices cover a broad range of equipment used across hospital departments. The FDA review panel code is HO.

This is one of the largest 510(k) categories, with 17,707 submissions since 1976. It includes:

  • Infusion and delivery systems - IV pumps, syringe drivers, enteral feeding
  • Vascular access devices - IV catheters, PICC lines, ports
  • Hospital beds and patient handling - adjustable beds, transfer devices
  • Sterilization and disinfection - autoclaves, chemical disinfectants, endoscope reprocessors
  • Wound care - negative pressure wound therapy, dressings

17791
Total
17765
Cleared
158d
Avg (2y)
1976
Since
11925 General Hospital devices
6526–6550 of 11925
Cleared Feb 15, 2002
PARAGON INFUSION SYSTEM
K020251 · I-Flow Corp.
FRN · Pump, Infusion · 22d
Cleared Feb 14, 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317 · Sgmp Co., Ltd.
LZA · Polymer Patient Examination Glove · 15d
Cleared Feb 13, 2002
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · Advanced Sterilization Products
FRC · Indicator, Biological Sterilization Process · 806d
Cleared Feb 13, 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
K014288 · Wrp Specialty Products Sdn. Bhd.
KGO · Surgeon's Gloves · 47d
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073 · Portex, Inc.
FMF · Syringe, Piston · 65d
Cleared Jan 23, 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K020019 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 20d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
K013795 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 69d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K013794 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 69d
Cleared Jan 22, 2002
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS
K013793 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 69d
Cleared Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 38d
Cleared Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 38d
Cleared Jan 08, 2002
BOEHRINGER MRI SUCTION REGULATORY
K013976 · Boehringer Laboratories
KDP · Regulator, Vacuum · 36d
Cleared Dec 31, 2001
STRYKER PAINPUMP
K014091 · Stryker Corp.
FRN · Pump, Infusion · 19d
Cleared Dec 31, 2001
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · Wrp Specialty Products Sdn. Bhd.
LYY · Latex Patient Examination Glove · 32d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
K013800 · Becton Dickinson Infusion Therapy Systems, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 36d
Cleared Dec 19, 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · Arista Latindo Industrial Ltd. P.T
LYY · Latex Patient Examination Glove · 75d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp.
KGO · Surgeon's Gloves · 75d
Cleared Dec 14, 2001
NIPRO HYPODERMIC NEEDLE
K013293 · Nipro Medical Corp.
FMI · Needle, Hypodermic, Single Lumen · 73d
Cleared Dec 12, 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
K013767 · Sterling Medivations, Inc.
FRN · Pump, Infusion · 29d
Cleared Dec 07, 2001
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · Riley Medical, Inc.
FRG · Wrap, Sterilization · 780d
Cleared Dec 07, 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · Smart Glove Corp. Sdn Bhd
KGO · Surgeon's Gloves · 28d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928 · Breg, Inc.
MEB · Pump, Infusion, Elastomeric · 5d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 42d
Cleared Dec 03, 2001
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
K013288 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 62d
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287 · Nipro Medical Corp.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 62d

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All categories 11925 LZA Polymer Patient Examination Glove 1057 FPA Set, Administration, Intravascular 800 LYY Latex Patient Examination Glove 672 FRN Pump, Infusion 605 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 512 FXX Mask, Surgical 510 FMF Syringe, Piston 498 FMI Needle, Hypodermic, Single Lumen 491 FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days 416 KGO Surgeon's Gloves 366 KKX Drape, Surgical 276 LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days 263 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238