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
6501–6525 of 11925
Cleared May 02, 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc.
FLL · Continuous Measurement Thermometer · 79d
Cleared Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
K021005 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 28d
Cleared Apr 22, 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company
JOJ · Indicator, Physical/chemical Sterilization Process · 59d
Cleared Apr 19, 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · Engineered Medical Systems
CAH · Filter, Bacterial, Breathing-circuit · 212d
Cleared Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · Micro Therapeutics, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 8d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc.
FRN · Pump, Infusion · 23d
Cleared Apr 16, 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
K013621 · Becton Dickinson Infusion Therapy Systems, Inc.
FPA · Set, Administration, Intravascular · 162d
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435 · Applied Medical Resources Corp.
KKX · Drape, Surgical · 66d
Cleared Apr 10, 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K020990 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 14d
Cleared Apr 10, 2002
SIMPLICITY EASY SOFT INFUSION SET
K020912 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 21d
Cleared Apr 04, 2002
PAIN CARE 4200
K020988 · Breg, Inc.
MEB · Pump, Infusion, Elastomeric · 8d
Cleared Apr 03, 2002
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · Medtronic Perfusion Systems
FMF · Syringe, Piston · 77d
Cleared Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 34d
Cleared Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
K013871 · Horizon Medical Products, Inc.
FPA · Set, Administration, Intravascular · 128d
Cleared Mar 26, 2002
I-FLOW ELASTOMERIC PUMP
K020862 · I-Flow Corp.
MEB · Pump, Infusion, Elastomeric · 8d
Cleared Mar 25, 2002
3M ATTEST 290 AUTO-READER
K004009 · 3M Company
FRC · Indicator, Biological Sterilization Process · 454d
Cleared Mar 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp.
MEB · Pump, Infusion, Elastomeric · 19d
Cleared Mar 18, 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp.
FYA · Gown, Surgical · 24d
Cleared Mar 14, 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · Engineered Medical Systems
CAH · Filter, Bacterial, Breathing-circuit · 178d
Cleared Mar 12, 2002
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp
KPE · Container, I.v. · 27d
Cleared Mar 08, 2002
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
K013267 · Siam Sempermed Corp., Ltd.
LYY · Latex Patient Examination Glove · 158d
Cleared Mar 06, 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · Dynarex Corp.
KKX · Drape, Surgical · 183d
Cleared Feb 28, 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
K014112 · Siam Sempermed Corp., Ltd.
LYY · Latex Patient Examination Glove · 76d
Cleared Feb 28, 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
K014110 · Siam Sempermed Corp., Ltd.
LYY · Latex Patient Examination Glove · 76d
Cleared Feb 26, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · Syntex Healthcare Products Co., Ltd.
LZA · Polymer Patient Examination Glove · 13d

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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