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
6676–6700 of 11936
Cleared Feb 16, 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc.
FYA · Gown, Surgical · 73d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp.
LZC · Medical Glove, Specialty · 23d
Cleared Feb 12, 2001
VORTEX ACCESS SYSTEM
K010189 · Horizon Medical Products, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 21d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp.
FMF · Syringe, Piston · 84d
Cleared Feb 09, 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · Tuttnauer U.S.A Co, Ltd.
FLE · Sterilizer, Steam · 452d
Cleared Feb 09, 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
K010095 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 29d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K004048 · Tillotson Healthcare Corp.
LYY · Latex Patient Examination Glove · 39d
Cleared Feb 01, 2001
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
K003840 · I.C Medical, Inc.
FYD · Apparatus, Exhaust, Surgical · 51d
Cleared Feb 01, 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)
K003737 · Perusahaan Getah Asas Sdn. Bhd.
LYY · Latex Patient Examination Glove · 59d
Cleared Feb 01, 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI · Needle, Hypodermic, Single Lumen · 86d
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · Wrp Asia Pacific Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 17d
Cleared Jan 26, 2001
MEDCOMP Z-CATH
K003682 · Medical Components, Inc.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 57d
Cleared Jan 26, 2001
PATIENT DRAPE, SURGICAL
K003670 · Advance Medical Designs, Inc.
KKX · Drape, Surgical · 59d
Cleared Jan 26, 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K003653 · Wrp Asia Pacific Sdn. Bhd.
LYY · Latex Patient Examination Glove · 60d
Cleared Jan 26, 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc.
LYY · Latex Patient Examination Glove · 116d
Cleared Jan 26, 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
K002719 · Tillotson Healthcare Corp.
LYY · Latex Patient Examination Glove · 148d
Cleared Jan 24, 2001
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
K991618 · Propper Mfg. Co., Inc.
FRC · Indicator, Biological Sterilization Process · 624d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · Cook, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 20d
Cleared Jan 23, 2001
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc.
FRG · Wrap, Sterilization · 123d
Cleared Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
K003895 · Ansell Perry
KGO · Surgeon's Gloves · 30d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513 · Icu Medical, Inc.
FPA · Set, Administration, Intravascular · 58d
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories
FMF · Syringe, Piston · 130d
Cleared Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
K992424 · Plastimed Laboratoire Pharmaceutique
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 527d
Cleared Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · Avita Corporation
FLL · Continuous Measurement Thermometer · 163d
Cleared Dec 29, 2000
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · Sterling Medivations, Inc.
FMF · Syringe, Piston · 168d

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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