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
11932 General Hospital devices
6601–6625 of 11932
Cleared Aug 27, 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · Terumo Medical Corp.
FMI · Needle, Hypodermic, Single Lumen · 14d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 48d
Cleared Aug 14, 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp.
KGO · Surgeon's Gloves · 71d
Cleared Aug 10, 2001
SIMPLICITY EURO QD INFUSION SET
K012330 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 18d
Cleared Aug 10, 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc.
FPA · Set, Administration, Intravascular · 51d
Cleared Aug 06, 2001
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd.
LYZ · Vinyl Patient Examination Glove · 17d
Cleared Aug 01, 2001
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K012135 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 23d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · Ethicon Endo-Surgery, Inc.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 23d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · Boston Scientific Corp
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 232d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical
LBI · Unit, Neonatal Phototherapy · 62d
Cleared Jul 10, 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · Tillotson Healthcare Corp.
LZA · Polymer Patient Examination Glove · 56d
Cleared Jul 10, 2001
SURGICAL DRAPES
K011422 · Advance Medical Designs, Inc.
KKX · Drape, Surgical · 62d
Cleared Jul 09, 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
K011728 · Brightway Holdings Sdn. Bhd.
LYY · Latex Patient Examination Glove · 35d
Cleared Jul 09, 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K011482 · Wrp Asia Pacific Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 56d
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp.
LZA · Polymer Patient Examination Glove · 31d
Cleared Jun 28, 2001
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp
MEB · Pump, Infusion, Elastomeric · 59d
Cleared Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
K011755 · Stryker Corp.
LYU · Accessory, Surgical Apparel · 16d
Cleared Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297 · Nipro Medical Corp.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 51d
Cleared Jun 20, 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
K010410 · Jms Co., Ltd.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 128d
Cleared Jun 20, 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
K010406 · Jms Co., Ltd.
FOZ · Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days · 128d
Cleared Jun 19, 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187 · Sterling Medivations, Inc.
FPA · Set, Administration, Intravascular · 62d
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp.
CAH · Filter, Bacterial, Breathing-circuit · 56d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
K011370 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d

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All categories 11932 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 512 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 263 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238