510(k) Report

FDA applicant

Samsara Vision, Inc.

Far Hills1 decision2010–20100 recalls

FDA records 1 decision for Samsara Vision, Inc. (Far Hills) in 2010: 1 original PMA approval. All are in product code NCJ (Telescope, Implantable, Miniature). 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Samsara Vision, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Samsara Vision, 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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