510(k) Report

FDA applicant

Waltham Div. Hewlett Packard

Waltham, MA1 decision1989–19890 recalls

FDA records 1 decision for Waltham Div. Hewlett Packard (Waltham, MA) in 1989: 1 510(k) clearance. All are in product code DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Waltham Div. Hewlett Packard’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Waltham Div. Hewlett Packard since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Waltham Div. Hewlett Packard by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)1decision

Who builds on its devices?

Later devices cite its devices 8 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.

  • K882609Models M1175A & M1176A Component Monitoring SystemWaltham Div. Hewlett Packard · 19898cite it

What has FDA decided for it lately?

  • K882609Models M1175A & M1176A Component Monitoring SystemWaltham Div. Hewlett Packard · 1989

The one decision as Waltham Div. Hewlett Packard →