FDA applicant

Solace Therapeutics

Farmingham, MA4 decisions2013–20170 recalls

FDA records 4 decisions for Solace Therapeutics (Farmingham, MA) from 2013 to 2017: 4 510(k) clearances. Most are in product codes KNY (Accessories, Catheter, G-U) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Solace Therapeutics, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Solace Therapeutics’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2013high 2 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Solace Therapeutics by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Solace Therapeutics

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?