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
11914 General Hospital devices
6301–6325 of 11914
Cleared Aug 28, 2003
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
K032432 · Busse Hospital Disposables, Inc.
FMJ · Manometer, Spinal-fluid · 22d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING
K032294 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN
K032293 · Sgmp Co., Ltd.
LYY · Latex Patient Examination Glove · 34d
Cleared Aug 22, 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd.
KGO · Surgeon's Gloves · 11d
Cleared Aug 22, 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed
FRN · Pump, Infusion · 53d
Cleared Aug 19, 2003
VAXCEL PORT, MODELS 45-336 AND 45-338
K032375 · Boston Scientific Corp
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 18d
Cleared Aug 19, 2003
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
K031917 · Medtronic Minimed
FPA · Set, Administration, Intravascular · 57d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp
MEA · Pump, Infusion, Pca · 92d
Cleared Aug 18, 2003
STERRAD 200 STERILIZER
K030429 · Advanced Sterilization Products
MLR · Sterilizer, Chemical · 189d
Cleared Aug 15, 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · Microlife Intellectual Property GmbH
FLL · Continuous Measurement Thermometer · 51d
Cleared Aug 11, 2003
ULTRASITE VALVE
K031923 · B.Braun Medical, Inc.
FPA · Set, Administration, Intravascular · 49d
Cleared Aug 05, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282 · LeMaitre Vascular, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 105d
Cleared Aug 01, 2003
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
K031768 · Perusahaan Getah Asas Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 53d
Cleared Aug 01, 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
K031625 · Perusahaan Getah Asas Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 66d
Cleared Jul 25, 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K032147 · Alaris Medical Systems, Inc.
FRN · Pump, Infusion · 11d
Cleared Jul 21, 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · Stryker Instruments
FRN · Pump, Infusion · 94d
Cleared Jul 15, 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
K031844 · Boston Scientific Corp
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 29d
Cleared Jul 15, 2003
B. BRAUN NERVE BLOCK CATHETER
K030830 · B.Braun Medical, Inc.
MEB · Pump, Infusion, Elastomeric · 123d
Cleared Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
K032008 · Boston Scientific Corp
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 14d
Cleared Jul 11, 2003
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · Medrad, Inc.
FPK · Tubing, Fluid Delivery · 29d
Cleared Jul 10, 2003
X-PROT DUO PORT
K032044 · C.R. Bard, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 8d
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

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All categories 11914 LZA Polymer Patient Examination Glove 1056 FPA Set, Administration, Intravascular 799 LYY Latex Patient Examination Glove 672 FRN Pump, Infusion 605 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 510 FXX Mask, Surgical 510 FMF Syringe, Piston 497 FMI Needle, Hypodermic, Single Lumen 489 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