510(k) Report

FDA applicant

Sub-Q, Inc.

San Clemente, CA3 decisions1998–20020 recalls

FDA records 3 decisions for Sub-Q, Inc. (San Clemente, CA) from 1998 to 2002: 2 510(k) clearances and 1 original PMA approval. Most are in product codes KYZ (Syringe, Irrigating (Non Dental)) and MGB (Device, Hemostasis, Vascular). 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, general hospital panel, where it files most

How often FDA has decided Sub-Q, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sub-Q, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KYZSyringe, Irrigating (Non Dental)2decisions
  • MGBDevice, Hemostasis, Vascular1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • P010049Quickseal Femoral Arterial Closure SystemSub-Q, Inc. · 20021cites it

What has FDA decided for it lately?

  • P010049Quickseal Femoral Arterial Closure SystemSub-Q, Inc. · 2002
  • K991254QS Delivery SystemSub-Q, Inc. · 1999
  • K982435Irrigation Syringe KitSub-Q, Inc. · 1998

All 3 as Sub-Q, Inc. →