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
11936 General Hospital devices
6651–6675 of 11936
Cleared Apr 30, 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl.
FMF · Syringe, Piston · 52d
Cleared Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 36d
Cleared Apr 18, 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 43d
Cleared Apr 13, 2001
SIMPLICITY INFUSER INFUSION SET
K010647 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 39d
Cleared Apr 12, 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 22d
Cleared Apr 11, 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · Avita Corporation
FLL · Continuous Measurement Thermometer · 54d
Cleared Apr 10, 2001
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767 · Horizon Medical Products, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 27d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719 · Perusahaan Getah Asas Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 29d
Cleared Apr 10, 2001
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K010486 · Pt. Medisafe Technologies
LZA · Polymer Patient Examination Glove · 49d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · Abbott Laboratories
FRN · Pump, Infusion · 10d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
K003350 · Pamitex Industries Sdn Bhd
LYY · Latex Patient Examination Glove · 161d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · La Glove (M) Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860 · La Glove (M) Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 12d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · Shen Wei (Usa), Inc.
LZA · Polymer Patient Examination Glove · 81d
Cleared Mar 30, 2001
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
K994381 · Raven Biological Laboratories, Inc.
FRC · Indicator, Biological Sterilization Process · 458d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097 · Shen Wei (Usa), Inc.
LZA · Polymer Patient Examination Glove · 78d
Cleared Mar 21, 2001
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222 · Ohmeda Medical
FMZ · Incubator, Neonatal · 56d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · Bd Becton Dickinson Vacutainer Systems Preanalytic
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 124d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp.
FPA · Set, Administration, Intravascular · 62d
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 34d
Cleared Mar 09, 2001
SLEEVED FILTER
K010040 · King Systems Corp.
CAH · Filter, Bacterial, Breathing-circuit · 63d
Cleared Mar 08, 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426 · Sims Deltec, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 23d
Cleared Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc.
FPA · Set, Administration, Intravascular · 189d
Cleared Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021 · Medical Components, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 51d
Cleared Feb 16, 2001
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
K010297 · Maxxim Medical
LZA · Polymer Patient Examination Glove · 16d

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All categories 11936 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 514 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 264 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238