510(k) Report

FDA applicant

Bimini Health Tech

Solana Beach1 decision2014–20141 recall

FDA records 1 decision for Bimini Health Tech (Solana Beach) in 2014: 1 original PMA approval. All are in product code FWM (Prosthesis, Breast, Inflatable, Internal, Saline). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Bimini Health Tech’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2014high 1 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Bimini Health Tech by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bimini Health Tech’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FWMProsthesis, Breast, Inflatable, Internal, Saline1decision

What has FDA decided for it lately?

  • P120011Puregraft Serene Breast ImplantBimini Health Tech · 20141 recall

The one decision as Bimini Health Tech →

What has been recalled?

1 recall linked to its devices; the latest:

  • P120011IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes…Mar 18, 2019Class II