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
11945 General Hospital devices
6751–6775 of 11945
Cleared Sep 19, 2000
PAIN CARE 3000
K002073 · Breg, Inc.
MEB · Pump, Infusion, Elastomeric · 71d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · Baxter Healthcare Corp
FRN · Pump, Infusion · 21d
Cleared Sep 18, 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · Purna Bina Sdn Bhd
LYY · Latex Patient Examination Glove · 264d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp
MEA · Pump, Infusion, Pca · 10d
Cleared Sep 08, 2000
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
K002579 · Wrp Specialty Products Sdn. Bhd.
LYY · Latex Patient Examination Glove · 21d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · Baxter Healthcare Corp
FRN · Pump, Infusion · 32d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp.
KKX · Drape, Surgical · 17d
Cleared Aug 29, 2000
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products
MED · Sterilant, Medical Devices · 22d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · Nien Made Electrnics Corp.
FLL · Continuous Measurement Thermometer · 275d
Cleared Aug 17, 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · Perusahaan Getah Asas Sdn. Bhd.
LYY · Latex Patient Examination Glove · 17d
Cleared Aug 17, 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · Medivators, Inc.
MED · Sterilant, Medical Devices · 342d
Cleared Aug 14, 2000
NEOLUS NEEDLE
K001572 · Terumo Europe N.V.
FMI · Needle, Hypodermic, Single Lumen · 84d
Cleared Aug 14, 2000
PAIN CARE 2000L
K002321 · Breg, Inc.
MEB · Pump, Infusion, Elastomeric · 14d
Cleared Aug 11, 2000
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124 · Mapa Professional
LZA · Polymer Patient Examination Glove · 248d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories
FPA · Set, Administration, Intravascular · 38d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · Allegiance Healthcare Corp.
FRG · Wrap, Sterilization · 683d
Cleared Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052 · Vygon Corp.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 325d
Cleared Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
K993442 · Vygon Corp.
LJS · Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days · 296d
Cleared Aug 01, 2000
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
K993524 · Alaris Medical Systems, Inc.
FRN · Pump, Infusion · 288d
Cleared Jul 31, 2000
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
K001690 · Johnson & Johnson Medical, Inc.
FMI · Needle, Hypodermic, Single Lumen · 59d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
K002175 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 12d
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

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All categories 11945 LZA Polymer Patient Examination Glove 1057 FPA Set, Administration, Intravascular 801 LYY Latex Patient Examination Glove 672 FRN Pump, Infusion 606 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 518 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 265 LJT Port & Catheter, Implanted, Subcutaneous, Intravascular 242 KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 238