510(k) Report

FDA applicant

Blakbag, Ltd., Division of Coherent Systems

Houston, TX1 decision1999–19990 recalls

FDA records 1 decision for Blakbag, Ltd., Division of Coherent Systems (Houston, TX) in 1999: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). Its devices cite 3 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, cardiovascular panel, where it files most

How often FDA has decided Blakbag, Ltd., Division of Coherent Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blakbag, Ltd., Division of Coherent Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Blakbag, Ltd., Division of Coherent Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blakbag, Ltd., Division of Coherent…’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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K982034E-Fax SystemBlakbag, Ltd., Division of Coherent Systems · 1999

The one decision as Blakbag, Ltd., Division of Coherent Systems →