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
11949 General Hospital devices
6826–6850 of 11949
Cleared Apr 21, 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · Allegiance Healthcare Corp.
FRG · Wrap, Sterilization · 158d
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · Sgmp Co., Ltd.
LZA · Polymer Patient Examination Glove · 34d
Cleared Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732 · Dumex Medical Surgical Products, Ltd.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 251d
Cleared Apr 14, 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 18d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K000390 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 65d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000391 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 65d
Cleared Apr 12, 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
K991677 · London International Group, Inc.
LYY · Latex Patient Examination Glove · 331d
Cleared Apr 12, 2000
IQ CHAMBERS
K992553 · Dormer Laboratories, Inc.
KXF · Applicator, Absorbent Tipped, Non-sterile · 257d
Cleared Apr 12, 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116 · A&D Engineering, Inc.
FLL · Continuous Measurement Thermometer · 205d
Cleared Apr 12, 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 131d
Cleared Apr 11, 2000
BODYGUARD
K000441 · Vital Signs, Inc.
FMI · Needle, Hypodermic, Single Lumen · 61d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · Pamitex Industries Sdn Bhd
LYY · Latex Patient Examination Glove · 24d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235 · Becton Dickinson Infusion Therapy Systems, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 69d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · Siam Sempermed Corp., Ltd.
LZA · Polymer Patient Examination Glove · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · Siam Sempermed Corp., Ltd.
LZA · Polymer Patient Examination Glove · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · Siam Sempermed Corp., Ltd.
LZA · Polymer Patient Examination Glove · 63d
Cleared Mar 31, 2000
HYDROCISION DEBDRIDEMENT SYSTEM
K991383 · Hydrocision, Inc.
FQH · Lavage, Jet · 345d
Cleared Mar 29, 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
K000671 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 30d
Cleared Mar 29, 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · Shijiazhuang Great Vision Plastic Products Co., LT
LYZ · Vinyl Patient Examination Glove · 243d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · Pamitex Industries Sdn Bhd
KGO · Surgeon's Gloves · 187d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
K000821 · Abbott Laboratories
FRN · Pump, Infusion · 10d
Cleared Mar 24, 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · Ultimed, Inc.
FMF · Syringe, Piston · 99d
Cleared Mar 20, 2000
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
K000488 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 35d
Cleared Mar 17, 2000
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation
FLE · Sterilizer, Steam · 66d
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087 · The Kendal Co.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 65d

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All categories 11949 LZA Polymer Patient Examination Glove 1057 FPA Set, Administration, Intravascular 801 LYY Latex Patient Examination Glove 673 FRN Pump, Infusion 606 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 519 FXX Mask, Surgical 511 FMF Syringe, Piston 499 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 265 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238