510(k) Report

FDA applicant

Blockade Medical, LLC (D.B.A. Balt Usa)

Irvine, CA1 decision2018–20184 recalls

FDA records 1 decision for Blockade Medical, LLC (D.B.A. Balt Usa) (Irvine, CA) in 2018: 1 510(k) clearance. All are in product code HCG (Device, Neurovascular Embolization). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are 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 Blockade Medical, LLC (D.B.A. Balt Usa)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 22024: 12025: 1
2018high 2 (2022) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Blockade Medical, LLC (D.B.A. Balt Usa) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blockade Medical, LLC (D.B.A. Balt Usa)’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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Which product codes does it file in?

  • HCGDevice, Neurovascular Embolization1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa) · 20181cites it

What has FDA decided for it lately?

  • K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa) · 20184 recalls

The one decision as Blockade Medical, LLC (D.B.A. Balt Usa) →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K172390Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK…May 8, 2025Class II
  • K200030Neurovascular embolization device. The Optima Coil System is a series specialized coils…Jan 3, 2024Class II
  • K200030Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in…Sep 7, 2022Class II
  • K172390Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Jul 26, 2022Class II

Other applicant names beginning “Blockade”

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

Blockade Medical 6