FDA applicant
Spectrum Medical, Ltd.
FDA records 23 decisions for Spectrum Medical, Ltd. (Gloucester, GB) from 2006 to 2026: 23 510(k) clearances. Most are in product codes DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…) and DTX (Gas Control Unit, Cardiopulmonary Bypass). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 11 of them its own earlier devices. 3 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Spectrum Medical S.R.L.”, “Spectrum Medical, Llp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spectrum Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Spectrum Medical, Ltd.’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 “Spectrum”
FDA records each applicant name separately; these may or may not be the same firm.