510(k) Report

FDA applicant

Zertl Medical, Inc.

Lawrenceville, NJ1 decision1993–19930 recalls

FDA records 1 decision for Zertl Medical, Inc. (Lawrenceville, NJ) in 1993: 1 510(k) clearance. All are in product code DPW (Flowmeter, Blood, Cardiovascular). 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 Zertl Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zertl Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zertl Medical, 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

Which product codes does it file in?

  • DPWFlowmeter, Blood, Cardiovascular1decision

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.

  • K921377P/MeterZertl Medical, Inc. · 19931cites it

What has FDA decided for it lately?

  • K921377P/MeterZertl Medical, Inc. · 1993

The one decision as Zertl Medical, Inc. →