510(k) Report

FDA applicant

St Jude Medical, Crmd

Sunnyvale, CA1 decision2010–20100 recalls

FDA records 1 decision for St Jude Medical, Crmd (Sunnyvale, CA) in 2010: 1 510(k) clearance. All are in product code DTA (Tester, Pacemaker Electrode Function). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 St Jude Medical, Crmd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — St Jude Medical, Crmd by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like St Jude Medical, Crmd’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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Which product codes does it file in?

  • DTATester, Pacemaker Electrode Function1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010

The one decision as St Jude Medical, Crmd →