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
11932 General Hospital devices
6551–6575 of 11932
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
Cleared Dec 03, 2001
TRIMAX
K012268 · Standard Textile Co., Inc.
FYA · Gown, Surgical · 137d
Cleared Nov 29, 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
K013324 · Tillotson Healthcare Corp.
KGO · Surgeon's Gloves · 55d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · Stryker Instruments
FYD · Apparatus, Exhaust, Surgical · 84d
Cleared Nov 20, 2001
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K013782 · Disetronic Medical Systems
FMI · Needle, Hypodermic, Single Lumen · 6d
Cleared Nov 16, 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · Smart Glove Corp. Sdn Bhd
LYY · Latex Patient Examination Glove · 84d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd
LZA · Polymer Patient Examination Glove · 84d
Cleared Nov 13, 2001
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · Alaris Medical Systems, Inc.
LHI · Set, I.v. Fluid Transfer · 57d
Cleared Nov 13, 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · Kimberly-Clark Corp.
LYY · Latex Patient Examination Glove · 83d
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073 · Becton Dickinson Infusion Therapy Systems, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 55d
Cleared Nov 05, 2001
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
K002937 · Albert Browne , Ltd.
LRT · Indicator, Sterilization · 410d
Cleared Oct 29, 2001
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · Micromedics, Inc.
FMF · Syringe, Piston · 63d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc.
LGZ · Warmer, Thermal, Infusion Fluid · 62d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · Tillotson Healthcare Corp.
LZA · Polymer Patient Examination Glove · 42d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp.
FEB · Accessories, Cleaning, For Endoscope · 88d
Cleared Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp.
FPA · Set, Administration, Intravascular · 24d
Cleared Oct 12, 2001
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA
K013286 · Tillotson Healthcare Corp.
LYY · Latex Patient Examination Glove · 10d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · Standard Textile Co., Inc.
KKX · Drape, Surgical · 50d
Cleared Oct 09, 2001
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER
K012485 · King Systems Corp.
CAH · Filter, Bacterial, Breathing-circuit · 68d

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All categories 11932 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 511 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