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
6576–6600 of 11932
Cleared Oct 04, 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd.
CAH · Filter, Bacterial, Breathing-circuit · 387d
Cleared Oct 02, 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
K013104 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 15d
Cleared Oct 02, 2001
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
K012383 · Alaris Medical Systems, Inc.
FRN · Pump, Infusion · 67d
Cleared Oct 01, 2001
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K012876 · Wrp Specialty Products Sdn. Bhd.
LYY · Latex Patient Examination Glove · 35d
Cleared Oct 01, 2001
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
K012335 · Albert Browne , Ltd.
JOJ · Indicator, Physical/chemical Sterilization Process · 69d
Cleared Sep 26, 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · Smart Glove Corp. Sdn Bhd
KGO · Surgeon's Gloves · 55d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc.
LZA · Polymer Patient Examination Glove · 96d
Cleared Sep 24, 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp.
FYA · Gown, Surgical · 18d
Cleared Sep 24, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
K012149 · Allegiance Healthcare Corp.
LYY · Latex Patient Examination Glove · 76d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K012863 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 28d
Cleared Sep 21, 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
K012860 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 28d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O
K012857 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 28d
Cleared Sep 19, 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · B.Braun Medical, Inc.
FRN · Pump, Infusion · 86d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc.
FMF · Syringe, Piston · 162d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · Advance Medical Designs, Inc.
KKX · Drape, Surgical · 68d
Cleared Sep 17, 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613 · Shield Gloves Manufacturer (M) Sdn Bhd
LZA · Polymer Patient Examination Glove · 115d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 22d
Cleared Sep 11, 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K011066 · Smart Glove Corp. Sdn Bhd
KGO · Surgeon's Gloves · 155d
Cleared Sep 11, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K011045 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 159d
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 12d
Cleared Sep 10, 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation
FLL · Continuous Measurement Thermometer · 63d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K011044 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 158d
Cleared Sep 05, 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · Jms Co., Ltd.
FMI · Needle, Hypodermic, Single Lumen · 394d
Cleared Aug 29, 2001
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · Becton, Dickinson & CO
FMI · Needle, Hypodermic, Single Lumen · 64d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937 · Micro Therapeutics, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 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