510(k) Report

FDA applicant

Bridge Medical, Inc.

Plymouth, MN2 decisions1998–20111 recall

FDA records 2 decisions for Bridge Medical, Inc. (Plymouth, MN) from 1998 to 2011: 2 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and FRN (Pump, Infusion). Its devices cite 17 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Bridge Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bridge Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bridge Medical, Inc.’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?

  • DQYCatheter, Percutaneous1decision
  • FRNPump, Infusion1decision

Whose devices does it build on?

Its devices cite 17 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model…Bridge Medical, Inc. · 20115cite it

What has FDA decided for it lately?

  • K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model…Bridge Medical, Inc. · 20111 recall
  • K973593Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry…Bridge Medical, Inc. · 1998

All 2 as Bridge Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080987BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide…Jun 26, 2012Class II

Other applicant names beginning “Bridge”

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

Bridge TO Life, Ltd. 7