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
6776–6800 of 11949
Cleared Jul 31, 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE
K002176 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 12d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
K002211 · Baxter Healthcare Corp
FRN · Pump, Infusion · 7d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · Abbott Laboratories
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 63d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
K001739 · Allegiance Healthcare Corp.
LYY · Latex Patient Examination Glove · 49d
Cleared Jul 27, 2000
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · Ansell Perry
KGO · Surgeon's Gloves · 7d
Cleared Jul 26, 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K001959 · Hartalega Sdn Bhd
KGO · Surgeon's Gloves · 29d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033 · Becton Dickinson Infusion Therapy Systems, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 21d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories
FRN · Pump, Infusion · 6d
Cleared Jul 17, 2000
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc.
MEG · Syringe, Antistick · 236d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp.
KGO · Surgeon's Gloves · 21d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp
FMF · Syringe, Piston · 833d
Cleared Jun 30, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
K000952 · Pamitex Industries Sdn Bhd
LYY · Latex Patient Examination Glove · 98d
Cleared Jun 30, 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · Pamitex Industries Sdn Bhd
LYY · Latex Patient Examination Glove · 29d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp.
KKX · Drape, Surgical · 23d
Cleared Jun 23, 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · Pamitex Industries Sdn Bhd
LYY · Latex Patient Examination Glove · 22d
Cleared Jun 22, 2000
CLICKER
K994384 · Bioject, Inc.
KZE · Injector, Fluid, Non-electrically Powered · 177d
Cleared Jun 20, 2000
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
K993125 · Safety Medical Supply Int,., Inc.
FMI · Needle, Hypodermic, Single Lumen · 274d
Cleared Jun 15, 2000
STERRAD 100S STERILIZER
K991999 · Advanced Sterilization Products
MLR · Sterilizer, Chemical · 367d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532 · Baxter Healthcare Corp
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 320d
Cleared Jun 12, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
K001529 · Perusahaan Getah Asas Sdn. Bhd.
LYY · Latex Patient Examination Glove · 26d
Cleared Jun 12, 2000
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL
K993518 · Medefil, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 238d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp.
FMF · Syringe, Piston · 29d
Cleared Jun 09, 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
K001557 · Kossan Latex Industries(M)Sdn Bhd
LYY · Latex Patient Examination Glove · 21d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
K994199 · Custom Medical Products, Inc.
KKX · Drape, Surgical · 179d
Cleared Jun 08, 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · Sims Deltec, Inc.
FRN · Pump, Infusion · 85d

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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