General Hospital— FDA advisory panel HO
15,746 FDA 510(k) clearances across 248 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
- LZA — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
- FPA — Gravity Blood Sets with 200µm Filter
- FRN — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- LYZ — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
- FLL — Temperature probes (5 models)
- FMF — GraftGun Universal Graft Delivery System (GDS®)
- FMI — MOWANA Auto Duo
- FOZ — Ruby Intravascular Catheter
- FRG — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more
- LJS — Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
- LJT — FLEXI-PORT Power Injectable Implantable Port
- KCT — S.I.N. Instruments Kits
- JOJ — Endox Test Strips
- KMF — TearRepair Liquid Skin Protectant
Recent clearances in the General Hospital panel
all clearances- K260354 — Foster Plus-22L (SNK/CE-F22)
- K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
- K260427 — Lumicare (3 models)
- K263530 — V-Pro maX 2 Low Temperature Sterilization System
- K260822 — VERIFY RESI-TEST SWAB Protein Detection Indicator
- K260261 — Gravity Blood Sets with 200µm Filter
- K262084 — S.I.N. Instruments Kits
- K254094 — Endox High Level Disinfectant
- K260180 — Carecube Negative Pressure Isolation Chamber (1BY)
- K263267 — Endox Test Strips
Data sourced from openFDA. This site is unofficial and independent of the FDA.