510(k) Report

FDA applicant

Thermogenesis Corp.

Rancho Cordova, CA3 decisions1996–20080 recalls

FDA records 3 decisions for Thermogenesis Corp. (Rancho Cordova, CA) from 1996 to 2008: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and JQC (Centrifuges (Micro, Ultra, Refrigerated) For…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Thermogenesis Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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