FDA applicant

Datascope Corp., Patient Monitoring Division

Mahwh, NJ4 decisions2008–20136 recalls

FDA records 4 decisions for Datascope Corp., Patient Monitoring Division (Mahwh, NJ) from 2008 to 2013: 4 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 8 predicates, 1 of them its own earlier devices. 6 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, cardiovascular panel, where it files most

How often FDA has decided Datascope Corp., Patient Monitoring Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2017

2008high 2 (2010) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Datascope Corp., Patient Monitoring Division by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Datascope Corp., Patient Monitoring…’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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Other applicant names beginning “Datascope”

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

Datascope Corp. 137 Datascope Corp., Cardiac Assist Division 4

Datascope Corp., Patient Monitoring Division

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?

What has been recalled?

Other applicant names beginning “Datascope”