510(k) Report

FDA applicant

Dayspring Medical, Inc.

Boulder, CO5 decisions1996–19990 recalls

FDA records 5 decisions for Dayspring Medical, Inc. (Boulder, CO) from 1996 to 1999: 5 510(k) clearances. Most are in product codes FJI (Dialyzer, Capillary, Hollow Fiber) and FKY (Connector, Tubing, Dialysate). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Dayspring Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dayspring Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dayspring Medical, Inc.’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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