General Hospital— FDA advisory panel HO
15,705 FDA 510(k) clearances across 247 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
The general hospital panel holds the infrastructure of everyday care: infusion pumps and their administration sets, hypodermic needles and syringes, clinical thermometers, examination gloves, hospital beds, patient lifts, and a wide band of home-use equipment. If a device touches nearly every patient and belongs to no specialty, it usually lands here.
Two things make this panel worth watching despite its unglamorous contents. First, infusion pumps are one of FDA's most recall-intense device categories — cross-referencing this panel's clearances against recall records is unusually informative. Second, the panel captures the consumer-facing edge of the device world: as monitoring and drug-delivery hardware migrates into the home, the general hospital panel is often where those 510(k)s file, so its recent-clearance list is a decent proxy for the home-care device market.
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the General Hospital panel
all codes- LYY — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- FPA — iiSure Infusion Set
- LZA — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- FRN — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- LYZ — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
- FLL — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
- FMF — Ultra-Fine SAFETY Insulin Syringe
- FMI — Profoject Pen Needles (Model A; Model B)
- FOZ — ClearSafe Closed System
- FRG — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
- LJS — Neonav ECG Tip Location System
- LJT — FLEXI-PORT Power Injectable Implantable Port
- KCT — SteriBest® Sterilization Tray System
- JOJ — LF Process Indicator Tape for Steam Sterilization
- KMF — TearRepair Liquid Skin Protectant
Recent clearances in the General Hospital panel
all clearances- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- K254285 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K261041 — ClearSafe Closed System
- K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter
- K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Data sourced from openFDA. This site is unofficial and independent of the FDA.