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
Cleared
Jan 24, 2001
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
FRC
Indicator, Biological Sterilization Process
624d
Cleared
Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
FOZ
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
20d
Cleared
Jan 23, 2001
MEDLINE STERILIZATION WRAP
FRG
Wrap, Sterilization
123d
Cleared
Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
KGO
Surgeon's Gloves
30d
Cleared
Jan 11, 2001
TAXOL ADMINISTRATION SET
FPA
Set, Administration, Intravascular
58d
Cleared
Jan 08, 2001
STERILE PISTON SYRINGE
FMF
Syringe, Piston
130d
Cleared
Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
LJS
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
527d
Cleared
Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
FLL
Continuous Measurement Thermometer
163d
Cleared
Dec 29, 2000
INJECTRITE-C15 AND INJECTRITE-C30
FMF
Syringe, Piston
168d
Cleared
Dec 21, 2000
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
LYY
Latex Patient Examination Glove
34d
Cleared
Dec 21, 2000
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
LYY
Latex Patient Examination Glove
34d
Cleared
Dec 20, 2000
CHEMO-AIDE DISPENSING PIN
LHI
Set, I.v. Fluid Transfer
16d
Cleared
Dec 13, 2000
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
FRN
Pump, Infusion
21d
Cleared
Dec 13, 2000
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
FPA
Set, Administration, Intravascular
55d
Cleared
Dec 12, 2000
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
FRN
Pump, Infusion
20d
Cleared
Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
FOZ
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
48d
Cleared
Dec 04, 2000
INFUSOMAT P
FRN
Pump, Infusion
67d
Cleared
Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
LZA
Polymer Patient Examination Glove
122d
Cleared
Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
LJS
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
58d
Cleared
Nov 29, 2000
B-D ULTRA-FINE III PEN NEEDLE
FMI
Needle, Hypodermic, Single Lumen
69d
Cleared
Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
LZA
Polymer Patient Examination Glove
117d
Cleared
Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
LZA
Polymer Patient Examination Glove
117d
Cleared
Nov 29, 2000
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
KGO
Surgeon's Gloves
100d
Cleared
Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
LZA
Polymer Patient Examination Glove
144d
Cleared
Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
LZA
Polymer Patient Examination Glove
27d
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