510(k) Report

FDA applicant

Spacelabs Medical, Inc.

Redmond, WA35 decisions1993–201237 recalls

FDA records 35 decisions for Spacelabs Medical, Inc. (Redmond, WA) from 1993 to 2012: 35 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 56 predicates, 23 of them its own earlier devices. 37 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 Spacelabs Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12009: 12010: 12011: 12012: 1
2007high 1 (2007) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2025

2007: 22008: 52009: 52010: 32011: 42012: 42013: 22014: 22015: 32025: 3
2007high 5 (2008) · low 0 (2016)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia13decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)7decisions
  • MSXSystem, Network And Communication, Physiological Monitors2decisions
  • DXJDisplay, Cathode-Ray Tube, Medical2decisions
  • DQKComputer, Diagnostic, Programmable2decisions
  • OLWIndex-Generating Electroencephalograph Software2decisions

Also: BSZ (2), GWQ (1), CBR (1), HGM (1), DQA (1), DXN (1).

Whose devices does it build on?

Its devices cite 56 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 51 times; 23 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.

  • K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 19986cite it
  • K925510Model 90478 & 90479 Telemetry Rec. Module&HousingSpacelabs Medical, Inc. · 19945cite it
  • K102422Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 20103cite it
  • K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 19993cite it
  • K972282Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 19973cite it
  • K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 20063cite it

What has FDA decided for it lately?

  • K120616Spacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. · 20129 recalls
  • K112962Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc. · 20117 recalls
  • K102422Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 20103 recalls
  • K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 20092 recalls
  • K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 20081 recall
  • K063490Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 20071 recall
  • K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
  • K062278Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006

All 35 as Spacelabs Medical, Inc. →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K112962Brand Name: Branding is not applied to this product. Product Name: DVI display cables…Sep 5, 2025Class II
  • K112962Brand Name: Branding is not applied to this product. Product Name: DVI display cables…Sep 5, 2025Class II
  • K112962Brand Name: Branding is not applied to this product. Product Name: DVI display cables…Sep 5, 2025Class II
  • K120616Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either…May 8, 2015Class II
  • K120616Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube…Jan 28, 2015Class II
  • K112962Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare…Jan 28, 2015Class II

Other applicant names beginning “Spacelabs”

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

Spacelabs, Inc. 46Spacelabs Healthcare 20Spacelabs Burdick, Inc. 1Spacelabs Healthcare Medical Equipment (Suzhou) CO 1