FDA applicant

Lake Region Mfg., Inc.

Chaska, MN42 decisions1977–20103 recalls

FDA records 42 decisions for Lake Region Mfg., Inc. (Chaska, MN) from 1977 to 2010: 42 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 19 predicates, 14 of them its own earlier devices. 3 recalls are 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 Lake Region Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 4 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Lake”

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

Lake Region Medical 17 Lake Medical Products, Inc. 15 Lake Consumer Products, Inc. 1 Lake Pharmaceutical, Inc. 1

Lake Region Mfg., Inc.

Which product codes does it file in?

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 “Lake”