Data / Medical devices / United States / Bimini Health Tech

Bimini Health Tech: FDA-registered device maker in Plano, TX, United States, 1 510(k) clearance and 1 PMA approval

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

Bimini Health Tech is registered with the FDA (registration 3022978896) in Plano, TX, United States. It lists 6 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 22, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3022978896
Address: 8400 Belleview Drive Ste. 125, Plano, TX, United States, 75024
Owner or operator: Bimini Health Tech (10048045)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: May 30, 2017
Registered through: 2026
Brand names listed: Adaptive, Amplifine, AutoPose Restore, DIRECT2 Lid, DIRECT2 Lid, Drain Lever Replacement Kit, DIRECT2 Lid, Drain Port Replacement Kit, Dermapose Access, Dermapose Refresh and more

Devices it lists

Device	Product code	Class	Role	Source
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body Contouring	QKL	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Prosthesis, Breast, Inflatable, Internal, Saline	FWM	3	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Suction, Lipoplasty For Removal	QPB	2	Complaint file establishment, Repackager or relabeler, Specification developer	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
April 22, 2020	K200168	Dermapose Access	QPB	Substantially Equivalent	Puregraft, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 14, 2014	P120011	Puregraft Serene Breast Implant	FWM	26	February 11, 2025	accessdata.fda.gov

Compare with other makers

Updated February 11, 2025. 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.