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
11823 General Hospital devices
4776–4800 of 11823
Cleared Apr 02, 2009
ZETAJET
K090003 · Bioject, Inc.
KZE · Injector, Fluid, Non-electrically Powered · 90d
Cleared Apr 02, 2009
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K083482 · Cook Vascular, Inc.
FPA · Set, Administration, Intravascular · 129d
Cleared Mar 27, 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 29d
Cleared Mar 27, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · Kimberly-Clark Corp.
FRG · Wrap, Sterilization · 238d
Cleared Mar 25, 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp.
KKX · Drape, Surgical · 142d
Cleared Mar 23, 2009
PHASEAL PROTECTOR P14, P21, P28 AND P50
K090634 · Carmel Pharma Ab.
LHI · Set, I.v. Fluid Transfer · 14d
Cleared Mar 20, 2009
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K082689 · Spectra Medical Devices, Inc.
NGT · Saline, Vascular Access Flush · 186d
Cleared Mar 19, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · Tangshan Jiteng Plastic Products Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 20d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873 · Pfm Medical, Inc.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 80d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · Smith & Nephew, Inc.
KCT · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · 16d
Cleared Mar 16, 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES
K090514 · STERIS Corporation
FRC · Indicator, Biological Sterilization Process · 18d
Cleared Mar 16, 2009
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
K083763 · R4 Vascular, Inc.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 88d
Cleared Mar 16, 2009
SERIM DISINTEK GTA 2.1%, MODEL: 5164
K083295 · Serim Research Corp.
JOJ · Indicator, Physical/chemical Sterilization Process · 126d
Cleared Mar 12, 2009
SUPERCATH 5
K081953 · Togo Medikit Co., Ltd.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 246d
Cleared Mar 11, 2009
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
K083185 · Cadi Scientific Pte.Ltd
FLL · Continuous Measurement Thermometer · 133d
Cleared Mar 11, 2009
BIOCLEAN CHEMO SHIELD
K081970 · Nitritex (M) Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 244d
Cleared Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502 · U.S. Safety Syringes Co., Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 13d
Cleared Mar 10, 2009
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation
FLL · Continuous Measurement Thermometer · 21d
Cleared Mar 10, 2009
LOUSEBUSTER
K083206 · Larada Sciences
LJL · Detectors And Removers, Lice, (including Combs) · 130d
Cleared Mar 10, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · Zibo Goldenline Plastic Product Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 152d
Cleared Mar 06, 2009
BLACK NITRILE EXAMINATION GLOVES
K083908 · Innovative Gloves Co;, Ltd.
LZA · Polymer Patient Examination Glove · 66d
Cleared Mar 06, 2009
DUKAL SURGICAL DRAPE
K083320 · Dukal Corp.
KKX · Drape, Surgical · 114d
Cleared Mar 05, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd.
LZA · Polymer Patient Examination Glove · 78d
Cleared Mar 05, 2009
EMU-GRAPH 4 EMULATOR, MODEL CI 144
K083650 · Steritec Products, Inc.
JOJ · Indicator, Physical/chemical Sterilization Process · 86d
Cleared Mar 04, 2009
MODIFICATION TO SECURACATH, MODEL: SPK01
K083081 · Interrad Medical, Inc.
OKC · Implanted Subcutaneous Securement Catheter · 139d

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All categories 11823 LZA Polymer Patient Examination Glove 1051 FPA Set, Administration, Intravascular 798 LYY Latex Patient Examination Glove 670 FRN Pump, Infusion 602 FLL Continuous Measurement Thermometer 555 FXX Mask, Surgical 508 FMF Syringe, Piston 492 FMI Needle, Hypodermic, Single Lumen 486 LYZ Vinyl Patient Examination Glove 482 FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days 415 KGO Surgeon's Gloves 366 KKX Drape, Surgical 275 LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days 259 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 241 FRG Wrap, Sterilization 235