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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K254210

510(k) cleared

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

Hyundai Bioland Co., Ltd. · Sep 25, 2026 · K254210

FDA cleared the REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) from Hyundai Bioland Co., Ltd. on Sep 25, 2026 under K254210, a traditional 510(k). The device falls under product code NPM, Bone Grafting Material, Animal Source, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 29, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hyundai Bioland Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254210?

K254210 is the FDA 510(k) for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5), submitted by Hyundai Bioland Co., Ltd.. FDA's decision date was Sep 25, 2026, under product code NPM (Bone Grafting Material, Animal Source).

Who makes the REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

Hyundai Bioland Co., Ltd., based in Cheongju-Si, is the applicant of record for K254210.

How long did the K254210 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 25, 2026, 270 days later.

← All decisions in September 2026