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
11925 General Hospital devices
Cleared
Jul 02, 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
LYY
Latex Patient Examination Glove
53d
Cleared
Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
FMF
Syringe, Piston
90d
Cleared
Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
FOZ
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
280d
Cleared
Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
FMF
Syringe, Piston
115d
Cleared
Jun 11, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
LYY
Latex Patient Examination Glove
29d
Cleared
Jun 10, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
LYY
Latex Patient Examination Glove
31d
Cleared
Jun 10, 2002
TERUMO GAS FILTER
CAH
Filter, Bacterial, Breathing-circuit
73d
Cleared
Jun 07, 2002
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
LYY
Latex Patient Examination Glove
35d
Cleared
Jun 07, 2002
DUPLOREACH
FMF
Syringe, Piston
177d
Cleared
Jun 06, 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
LZA
Polymer Patient Examination Glove
76d
Cleared
May 22, 2002
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
LZA
Polymer Patient Examination Glove
54d
Cleared
May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
FPA
Set, Administration, Intravascular
11d
Cleared
May 17, 2002
SIMPLICITY EASY ACCESS P INFUSION SET
FPA
Set, Administration, Intravascular
9d
Cleared
May 17, 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
MEB
Pump, Infusion, Elastomeric
25d
Cleared
May 17, 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
FLE
Sterilizer, Steam
71d
Cleared
May 16, 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
LZA
Polymer Patient Examination Glove
14d
Cleared
May 15, 2002
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
DWL
Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
85d
Cleared
May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
FRN
Pump, Infusion
15d
Cleared
May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
FPA
Set, Administration, Intravascular
20d
Cleared
May 14, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
LYY
Latex Patient Examination Glove
42d
Cleared
May 14, 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
LYY
Latex Patient Examination Glove
42d
Cleared
May 09, 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
FMZ
Incubator, Neonatal
79d
Cleared
May 09, 2002
OHMEDA MEDICAL GIRAFFE OMNIBED
FMZ
Incubator, Neonatal
79d
Cleared
May 03, 2002
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
FPA
Set, Administration, Intravascular
16d
Cleared
May 02, 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
LZA
Polymer Patient Examination Glove
56d
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