FDA applicant

Point Robotics MedTech, Inc.

New Taipei City, TW5 decisions2022–20260 recalls

FDA records 5 decisions for Point Robotics MedTech, Inc. (New Taipei City, TW) from 2022 to 2026: 5 510(k) clearances. All are in product code OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 155 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 4 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, neurology panel, where it files most

How often FDA has decided Point Robotics MedTech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022high 2 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Point Robotics MedTech, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Point Robotics MedTech, 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 “Point”

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

Point of View Optical Outlet, Inc. 1

Point Robotics MedTech, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Point”