FDA applicant
Spacelabs Healthcare
FDA records 20 decisions for Spacelabs Healthcare (Nederland, CO) from 2011 to 2022: 20 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 259 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 6 of them its own earlier devices. 45 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Spacelabs Healthcare, Ltd.”, “Spacelabs Healthcare, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spacelabs Healthcare’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
8in 2026
Class I Class II/III not classified
Planning a device like Spacelabs Healthcare’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) ReportOther applicant names beginning “Spacelabs”
FDA records each applicant name separately; these may or may not be the same firm.