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
11955 General Hospital devices
6901–6925 of 11955
Cleared Feb 07, 2000
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K994201 · Perusahaan Pelindung Getah (M) Sdn Bhd
LYY · Latex Patient Examination Glove · 56d
Cleared Feb 07, 2000
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994206 · Shijiazhuang Hongray Plastic Products Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 55d
Cleared Feb 07, 2000
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994222 · Shijiazhuang Hongray Plastic Products Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 54d
Cleared Feb 07, 2000
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994250 · Tekmedic (M) Sdn Bhd
LYY · Latex Patient Examination Glove · 53d
Cleared Feb 07, 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · Pt. Maja Agung Latexindo
LYY · Latex Patient Examination Glove · 52d
Cleared Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl.
KKX · Drape, Surgical · 52d
Cleared Feb 03, 2000
VERSALET 7700 CARE CENTER, MODEL # 7700
K993051 · Hill-Rom Air-Shields
FMZ · Incubator, Neonatal · 143d
Cleared Feb 03, 2000
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K994136 · Shanghai Champion Plastic Products Co., Ltd.
LYZ · Vinyl Patient Examination Glove · 58d
Cleared Feb 03, 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416 · Flexitech Sdn. Bhd.
LYY · Latex Patient Examination Glove · 36d
Cleared Jan 31, 2000
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
K993857 · Ansell Perry
KGO · Surgeon's Gloves · 77d
Cleared Jan 31, 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246 · Omnigrace , Ltd.
LZA · Polymer Patient Examination Glove · 46d
Cleared Jan 31, 2000
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994354 · Flexitech Sdn. Bhd.
LYY · Latex Patient Examination Glove · 39d
Cleared Jan 28, 2000
HENRY SCHEIN SURGICAL MASK
K992604 · Mitsui Textile Corp.
FXX · Mask, Surgical · 178d
Cleared Jan 28, 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · Glove Source, Inc.
LZA · Polymer Patient Examination Glove · 58d
Cleared Jan 28, 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · Besglove Medicare Sdn. Bhd.
LYY · Latex Patient Examination Glove · 56d
Cleared Jan 28, 2000
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
K994248 · Shinemound Enterprise, Inc.
LYZ · Vinyl Patient Examination Glove · 43d
Cleared Jan 27, 2000
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL
K991023 · Case Medical, Inc.
FRG · Wrap, Sterilization · 304d
Cleared Jan 27, 2000
MILLENNIUM HUBER PLUS SAFETY INFUSION SET
K993848 · Millennium Medical Distribution, Inc.
FPA · Set, Administration, Intravascular · 76d
Cleared Jan 27, 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · Sims Deltec, Inc.
LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular · 43d
Cleared Jan 20, 2000
GOWN BACK, MODEL 13-403N
K992436 · Techstyles
FYA · Gown, Surgical · 182d
Cleared Jan 20, 2000
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
K992675 · Wear Safe Malaysia Sdn. Bhd.
LZA · Polymer Patient Examination Glove · 163d
Cleared Jan 20, 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · Supermax Sdn Bhd
LYY · Latex Patient Examination Glove · 66d
Cleared Jan 20, 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · Supermax Sdn Bhd
LYY · Latex Patient Examination Glove · 66d
Cleared Jan 20, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K994013 · Glovco (M) Sdn. Bhd.
LYY · Latex Patient Examination Glove · 55d
Cleared Jan 20, 2000
SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
K994258 · Shinemound Enterprise, Inc.
LYZ · Vinyl Patient Examination Glove · 34d

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All categories 11955 LZA Polymer Patient Examination Glove 1059 FPA Set, Administration, Intravascular 802 LYY Latex Patient Examination Glove 674 FRN Pump, Infusion 606 FLL Continuous Measurement Thermometer 557 LYZ Vinyl Patient Examination Glove 520 FXX Mask, Surgical 511 FMF Syringe, Piston 499 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