FDA applicant

Summa Therapeutics, LLC

Cambridge, MA3 decisions2015–20241 recall

FDA records 3 decisions for Summa Therapeutics, LLC (Cambridge, MA) from 2015 to 2024: 3 510(k) clearances. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Summa Therapeutics”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2015high 1 (2025) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Summa Therapeutics, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Summa”

FDA records each applicant name separately; these may or may not be the same firm.

Summa Medical Corp. 1 Summa Intl. 1

Summa Therapeutics, LLC

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?

What has been recalled?

Other applicant names beginning “Summa”