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

11918 General Hospital devices

6326–6350 of 11918

Cleared Jul 09, 2003

VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR

K031913 · Arista Latindo Industrial Ltd. P.T

LYZ · Vinyl Patient Examination Glove · 19d

Cleared Jul 08, 2003

TERUMO SURGUARD 2 SAFETY NEEDLE

K031453 · Terumo Medical Corp.

FMI · Needle, Hypodermic, Single Lumen · 62d

Cleared Jul 07, 2003

VENTLAB BACTERIAL FILTER, MODEL BF100

K030271 · Ventlab Corp.

CAH · Filter, Bacterial, Breathing-circuit · 161d

Cleared Jul 02, 2003

LIFEVALVE CENTRAL VENOUS CATHTER

K031718 · Horizon Medical Products, Inc.

LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 29d

Cleared Jun 26, 2003

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED

K031591 · Perusahaan Getah Asas Sdn. Bhd.

LZA · Polymer Patient Examination Glove · 36d

Cleared Jun 26, 2003

POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE

K031414 · Perusahaan Getah Asas Sdn. Bhd.

LYY · Latex Patient Examination Glove · 52d

Cleared Jun 25, 2003

DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR

K030990 · Datex-Ohmeda

CAH · Filter, Bacterial, Breathing-circuit · 89d

Cleared Jun 24, 2003

MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE

K031200 · Becton, Dickinson & CO

FMI · Needle, Hypodermic, Single Lumen · 69d

Cleared Jun 24, 2003

CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3

K024270 · Intersurgical, Inc.

CAH · Filter, Bacterial, Breathing-circuit · 183d

Cleared Jun 20, 2003

DATEX-OHMEDA HMEF 750

K031653 · Datex-Ohmeda

CAH · Filter, Bacterial, Breathing-circuit · 23d

Cleared Jun 19, 2003

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

K031626 · AngioDynamics, Inc.

LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 23d

Cleared Jun 17, 2003

MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G

K031384 · Yty Industry (Manjung) Sdn Bhd

LZA · Polymer Patient Examination Glove · 47d

Cleared Jun 13, 2003

CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE

K031021 · Perusahaan Getah Asas Sdn. Bhd.

LYY · Latex Patient Examination Glove · 74d

Cleared Jun 12, 2003

NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS

K030994 · Sgmp Co., Ltd.

LYY · Latex Patient Examination Glove · 76d

Cleared Jun 12, 2003

NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS

K030993 · Sgmp Co., Ltd.

LYY · Latex Patient Examination Glove · 76d

Cleared May 30, 2003

SURSHIELD SAFETY WINGED INFUSION SET

K031266 · Terumo Corp.

FPA · Set, Administration, Intravascular · 39d

Cleared May 30, 2003

STRYKER PAINPUMP2

K030661 · Stryker Instruments

MEA · Pump, Infusion, Pca · 88d

Cleared May 30, 2003

SPECTRUM SILICONE CATHETER

K021557 · Cook, Inc.

FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 382d

Cleared May 21, 2003

ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II

K030576 · The Anspach Effort, Inc.

FRN · Pump, Infusion · 86d

Cleared May 09, 2003

SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR

K030680 · Spsmedical Supply Corp.

JOJ · Indicator, Physical/chemical Sterilization Process · 65d

Cleared May 06, 2003

K030580 · Welch Allyn, Inc.

FLL · Continuous Measurement Thermometer · 71d

Cleared May 06, 2003

PEDIATRIC CENTRAL VENOUS CATHETER KIT

K023253 · B.Braun Medical, Inc.

FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 218d

Cleared May 05, 2003

POLY PER-Q-CATH PICC CATHETERS

K031129 · C.R. Bard, Inc.

LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 26d

Cleared May 02, 2003

STERRAD CYCLESURE BIOLOGICAL INDICATOR

K031226 · Advanced Sterilization Products

FRC · Indicator, Biological Sterilization Process · 14d

Cleared Apr 30, 2003

ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE

K031185 · Abbott Laboratories

FRN · Pump, Infusion · 15d

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