510(k) · Cleared
ClearedEMMA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inrange Systems, Inc. · NZH Medication Management System, Remote
Cleared on Feb 26, 2015 after a 31-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 26, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- NZH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NZH devicesNZH Medication Management System, Remote: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NZH
1in 2015
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
MAUDE reports naming product code NZH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The 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 command; and to provide to the medical provider a history of the event.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150174 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150174: EMMA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150174
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026