510(k) Report

FDA product code · Cardiovascular

Reprocessed Blood Pressure Cuff

NPPClass II21 CFR 870.1120510(k) required1 decision since 20030 recalls

1 FDA decision since 2003. No recall names this code.

The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of NPP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NPP

FDA has decided no NPP device since 2007.

Median 510(k) review, days · NPP

Too few NPP 510(k)s in any year since 2007 to give a median.

Recalls per year · NPP

No recall names NPP since 2007.

Adverse event reports per year · NPP

1in 2024

2019: 12020: 12021: 12024: 1
2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code NPP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—01
20210—01
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — NPP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NPP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 870.1120.