510(k) Report

FDA applicant

Spacelabs Healthcare Medical Equipment (Suzhou) CO

Nederland, CO1 decision2009–20091 recall

FDA records 1 decision for Spacelabs Healthcare Medical Equipment (Suzhou) CO (Nederland, CO) in 2009: 1 510(k) clearance. All are in product code MHX (Monitor, Physiological, Patient (With…). Its devices cite 5 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 Spacelabs Healthcare Medical Equipment (Suzhou) CO’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Spacelabs Healthcare Medical Equipment (Suzhou) CO by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 20094cite it

What has FDA decided for it lately?

  • K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 20091 recall

The one decision as Spacelabs Healthcare Medical Equipment (Suzhou) CO →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090556Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits…Jul 23, 2009

Other applicant names beginning “Spacelabs”

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

Spacelabs, Inc. 46Spacelabs Medical, Inc. 35Spacelabs Healthcare 20Spacelabs Burdick, Inc. 1