510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150174Substantially Equivalent

Emma

Inrange Systems, Inc., Altoona PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K150174 is the FDA 510(k) clearance record for EMMA, a class II device, cleared for Inrange Systems, Inc. on under FDA product code NZH (Medication Management System, Remote). FDA's definition for product code NZH reads: "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...". FDA records list 2 510(k) clearances for Inrange Systems, Inc., from to . As of , FDA records show no recalls naming K150174.

Clearance record

Decision date
Received
(31 days to decision)
Product code
NZH Medication Management System, Remote
Regulation
21 CFR 880.6315
Device class
Class II
Review panel
General Hospital
Applicant
Inrange Systems, Inc. 3316 5th Ave. - Suite 100, Altoona PA
510(k) summary
Statement
Third party review
No

Clearances, product code NZH

Trailing 12 months

FDA records hold no clearances under product code NZH in the trailing twelve months.

FDA records show no clearances under product code NZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260