FDA applicant

Hk Surgical, Inc.

Oceanside, CA4 decisions2003–20200 recalls

FDA records 4 decisions for Hk Surgical, Inc. (Oceanside, CA) from 2003 to 2020: 4 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and QPB (System, Suction, Lipoplasty For Removal). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hk Surgical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2020

2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hk Surgical, 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

Hk Surgical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?