510(k) Report

FDA product code · General hospital

Medication Management System, Remote

NZHClass II21 CFR 880.6315510(k) required2 decisions since 20070 recalls

2 FDA decisions since 2007. No recall names this code.

A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's…

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, general hospital panel

Twenty years of NZH 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 · NZH

1in 2015

2007: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZH

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

Recalls per year · NZH

No recall names NZH since 2007.

Adverse event reports per year · NZH

1in 2024

2008: 42009: 12010: 12016: 52017: 12024: 1
2007high 5 (2016) · low 0 (2007)2025

MAUDE reports naming product code NZH, 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
20071—00
20080—04
20090—01
20100—01
20110—00
20120—00
20130—00
20140—00
20151—00
20160—05
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — NZH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

See the 510(k) Report