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FDA 510(k)

BunkerHill BMD

K-Number: K242295 · 2025-04-08

ApplicantBunkerHill Health
Decision Date2025-04-08
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BunkerHill BMD is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K242295. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BunkerHill BMD?

BunkerHill BMD is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is BunkerHill Health. The 510(k) number is K242295.

When did BunkerHill BMD receive FDA 510(k) clearance?

BunkerHill BMD received FDA 510(k) clearance on 2025-04-08, under 510(k) number K242295.

Who is the listed applicant for BunkerHill BMD?

The FDA 510(k) record lists BunkerHill Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BunkerHill BMD?

The FDA product code for BunkerHill BMD is KGI.

Other records listing BunkerHill Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260167Bunkerhill Contrast AVCK260166Bunkerhill Contrast CACK250662Bunkerhill MACK250649Bunkerhill ECG-EFK243779Bunkerhill Abdominal Aortic Quantification (AAQ)K243229Bunkerhill AVC

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Related Devices (Code: KGI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. DiagnosticsK2208223D-SHAPER3D-Shaper Medical S.LK213760ABMD SoftwareHeartLung Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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