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
11914 General Hospital devices
6251–6275 of 11914
Cleared Jan 15, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · Microlife Intellectual Property GmbH
FLL · Continuous Measurement Thermometer · 17d
Cleared Jan 14, 2004
MODIFICATION TO V-CATH POLY PICC
K033853 · Hdc Corp.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 34d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290
K033818 · Microlife Intellectual Property GmbH
FLL · Continuous Measurement Thermometer · 30d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817 · Microlife Intellectual Property GmbH
FLL · Continuous Measurement Thermometer · 30d
Cleared Jan 08, 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · Smart Glove Corp. Sdn Bhd
LZA · Polymer Patient Examination Glove · 45d
Cleared Jan 08, 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc.
LYZ · Vinyl Patient Examination Glove · 59d
Cleared Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
K033250 · Edwards Lifesciences, LLC
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 84d
Cleared Dec 17, 2003
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 86d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories
FPA · Set, Administration, Intravascular · 21d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692 · Icu Medical, Inc.
FPA · Set, Administration, Intravascular · 561d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
K032940 · Brightway Holdings Sdn. Bhd.
LYY · Latex Patient Examination Glove · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
K032938 · Brightway Holdings Sdn. Bhd.
LYY · Latex Patient Examination Glove · 59d
Cleared Nov 20, 2003
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
K023537 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 395d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · Horizon Medical Products, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 15d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · Becton, Dickinson & CO
FPA · Set, Administration, Intravascular · 29d
Cleared Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777 · Nipro Medical Corp.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 67d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
K032444 · Cardinalhealth
LZC · Medical Glove, Specialty · 97d
Cleared Nov 10, 2003
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
K030583 · Shen Wei (Usa), Inc.
LYY · Latex Patient Examination Glove · 259d
Cleared Nov 07, 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 72d
Cleared Oct 31, 2003
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp.
FMF · Syringe, Piston · 240d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962 · Arrow Intl., Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 36d
Cleared Oct 29, 2003
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc.
LYZ · Vinyl Patient Examination Glove · 114d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc.
LZA · Polymer Patient Examination Glove · 121d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · Medtronic Minimed
FPA · Set, Administration, Intravascular · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · Medtronic Minimed
FPA · Set, Administration, Intravascular · 77d

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All categories 11914 LZA Polymer Patient Examination Glove 1056 FPA Set, Administration, Intravascular 799 LYY Latex Patient Examination Glove 672 FRN Pump, Infusion 605 FLL Continuous Measurement Thermometer 557 FXX Mask, Surgical 510 LYZ Vinyl Patient Examination Glove 510 FMF Syringe, Piston 497 FMI Needle, Hypodermic, Single Lumen 489 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