510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN200033Unknown

NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

Nightware, Hopkins MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN200033 is the FDA 510(k) clearance record for NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable, a class II device, cleared for Nightware, Inc. on under FDA product code QMZ (Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions). FDA's definition for product code QMZ reads: "A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who...". FDA records list one 510(k) clearance for Nightware, Inc. As of , FDA records show no recalls naming DEN200033.

Clearance record

Decision date
Received
(163 days to decision)
Product code
QMZ Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Regulation
21 CFR 882.5705
Device class
Class II
Review panel
Neurology
Applicant
Nightware, Inc. 153 Ashley Rd., Hopkins MN
Third party review
No

Clearances, product code QMZ

Trailing 12 months

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

FDA records show no clearances under product code QMZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMZ, 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