FDA applicant

Lead-Lok, Inc.

Sandpoint, ID5 decisions1989–20010 recalls

FDA records 5 decisions for Lead-Lok, Inc. (Sandpoint, ID) from 1989 to 2001: 5 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…). No 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 Lead-Lok, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lead-Lok, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lead-Lok, 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 “Lead-Lok”

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

Lead Technologies, Inc. 1

Lead-Lok, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lead-Lok”