510(k) Report

FDA applicant

Isto Technologies, Inc.

Chevy Chase, MD4 decisions2007–20110 recalls

FDA records 4 decisions for Isto Technologies, Inc. (Chevy Chase, MD) from 2007 to 2011: 4 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 7 predicates, 5 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, orthopedic panel, where it files most

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

FDA decisions per year

2in 2011

2007: 22011: 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 — Isto Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Isto Technologies, 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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