FDA applicant

Mastel Precision, Inc.

Irvine, CA1 decision2002–20020 recalls

FDA records 1 decision for Mastel Precision, Inc. (Irvine, CA) in 2002: 1 510(k) clearance. All are in product code KYB (Lens, Guide, Intraocular). Its devices cite 2 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Mastel Precision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Mastel”

FDA records each applicant name separately; these may or may not be the same firm.

Mastel Precision Surgical Instruments, Inc. 1 Mastel Surgical 1

Mastel Precision, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Mastel”