# K122516: Embletta MPR

- Pathway: 510(k) (Traditional)
- Applicant: Embla Systems
- Decided: Feb 21, 2013 after 188 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913396 (1992). 27 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041904: Compass F10 System, Medcare Flaga (2004) Summary page 1.
- K073682: Embletta Gold, Embla Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own
- K191031: NightOwl (2020), 5 descendants of its own
- K183559: WatchPAT ONE (2019), 5 descendants of its own
- K220095: ANNE Sleep (2022), 4 descendants of its own

## Recalls of this device
- Sep 29, 2026 · Not classified · Z-0319-2027: The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with i

## Indications for use
The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel. The Embletta MPR is intended to be used for adult and pediatric (excluding infants and neonatal) studies. The device is not equipped with alarms and is not intended to be used as a monitor. The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort. The device does not monitor or diagnose the patient and does not issue any alarms.

Source page: https://510kreport.com/device/K122516
Methodology: https://510kreport.com/methodology