# K073682: Embletta Gold

- Pathway: 510(k) (Traditional)
- Applicant: Embla Systems, Inc.
- Decided: Aug 8, 2008 after 224 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: 5 generations back to K913396 (1992). 26 ancestors in all.
41 later devices descend from it; 3 cite it directly.
0 of 68 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.
- K021176: Compumedics Somte System, Compumedics Limited (2003) Summary page 1.
- K031202: Medipalm-20, Braebon Medical Corp. (2003) Summary page 1.
- K042039: Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120, Cleveland Medical Devices, Inc. (2004) Summary page 1.

## Most influential descendants
- K122516: Embletta MPR (2013), 27 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 (2009), 7 descendants of its own
- K191031: NightOwl (2020), 5 descendants of its own

## Recalls of this device
- Apr 24, 2013 · Class II · Z-1532-2013: Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient

## Indications for use
The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters 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 Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor. The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.

Source page: https://510kreport.com/device/K073682
Methodology: https://510kreport.com/methodology