510(k) Report

FDA applicant

Novosci Corp.

The Woodlands, TX4 decisions2004–20070 recalls

FDA records 4 decisions for Novosci Corp. (The Woodlands, TX) from 2004 to 2007: 4 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Novosci, Inc.”.

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 Novosci Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novosci 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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