FDA applicant

Bridge TO Life, Ltd.

Northbrook, IL7 decisions2019–20261 recall

FDA records 7 decisions for Bridge TO Life, Ltd. (Northbrook, IL) from 2019 to 2026: 6 510(k) clearances and 1 De Novo grant. Most are in product codes KDN (System, Perfusion, Kidney) and SGY (Hypothermic Machine Perfusion System And…). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Bridge TO Life”.

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 Bridge TO Life, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2019high 4 (2025) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2025

2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Bridge TO Life, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bridge TO Life, Ltd.’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

Other applicant names beginning “Bridge”

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

Bridge Medical, Inc. 2

Bridge TO Life, Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Bridge”