Data / Medical devices / United States / Bunkerhill Health

Bunkerhill Health: FDA-registered device maker in San Francisco, CA, United States, 9 510(k) clearances

Name: Bunkerhill Health FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bunkerhill Health is registered with the FDA (registration 3027245002) in San Francisco, CA, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 6, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3027245002
Address: 144 2nd St Ste 100, San Francisco, CA, United States, 94105
Owner or operator: Bunkerhill Health (10087898)
Roles: Manufacturer
First device listed: April 27, 2023
Registered through: 2026
Brand names listed: BunkerHill BMD, Bunkerhill AVC, Bunkerhill Abdominal Aortic Quantification (AAQ), Bunkerhill Contrast AVC, Bunkerhill Contrast CAC, Bunkerhill ECG-EF, Bunkerhill MAC, CAC (gated) and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Densitometer, Bone	KGI	2	Manufacturer	accessdata.fda.gov
Reduced Ejection Fraction Machine Learning-Based Notification Software	QYE	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 6, 2026	K260167	Bunkerhill Contrast AVC	JAK	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
March 6, 2026	K260166	Bunkerhill Contrast CAC	JAK	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
October 3, 2025	K250662	Bunkerhill MAC	JAK	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
September 19, 2025	K250649	Bunkerhill ECG-EF	QYE	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
July 1, 2025	K243779	Bunkerhill Abdominal Aortic Quantification (AAQ)	QIH	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
April 8, 2025	K242295	BunkerHill BMD	KGI	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
January 27, 2025	K243229	Bunkerhill AVC	JAK	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
September 27, 2024	K240369	CAC (gated) Algorithm	JAK	Substantially Equivalent	BunkerHill Health	accessdata.fda.gov
April 25, 2023	K230223	iCAC Device	JAK	Substantially Equivalent	Bunkerhill, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.