# Embla Systems

- Location (FDA's records): Kanata, CA
- FDA decisions: 9 (2008–2019): 9 510(k) clearances
- Names in FDA's records: Embla Systems (8); Embla Systems, Inc. (1)
- Product codes: MNR (5), OLZ (3), GXY (1)
- 510(k) review time since 2016: median 216 days, against 122 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 20 (1 its own); citations of its devices by later devices: 9 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medcare Flaga: 4 (https://510kreport.com/company/medcare-flaga)
- Excel-Tech Ltd. (Xltek): 3 (https://510kreport.com/company/excel-tech-xltek)
- S.L.P., Ltd.: 2 (https://510kreport.com/company/slp)
- Edentec Corp.: 1 (https://510kreport.com/company/edentec)
- Rochester Electro Medical, Inc.: 1 (https://510kreport.com/company/rochester-electro-medical)
- Vermont Medical, Inc.: 1 (https://510kreport.com/company/vermont-medical)
- Airsep Corp.: 1 (https://510kreport.com/company/airsep)
- Ferguson Medical: 1 (https://510kreport.com/company/ferguson-medical)

## Firms that cite its devices most
- Kai Sensors, Inc.: 1 (https://510kreport.com/company/kai-sensors)
- MyCardio, LLC: 1 (https://510kreport.com/company/mycardio)
- Itamar Medical, Ltd.: 1 (https://510kreport.com/company/itamar-medical)
- Neurozone Msh Incorporated: 1 (https://510kreport.com/company/neurozone-msh)
- Onera B.V.: 1 (https://510kreport.com/company/onera)
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek): 1 (https://510kreport.com/company/natus-medical-dba-excel-tech-xltek)
- Cadwell Industries, Inc.: 1 (https://510kreport.com/company/cadwell-industries)
- Wesper, Inc.: 1 (https://510kreport.com/company/wesper)

## Its most-cited devices
- K122516: Embletta MPR (2013), cited by 3
- K073682: Embletta Gold (2008), cited by 3
- K173793: XactTrace Single Use Respiratory Effort Belt System (2019), cited by 1
- K153353: Sandman Elite (2016), cited by 1
- K111742: Mdrive (2011), cited by 1

## Recent decisions
- K180001: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (Sep 27, 2019)
- K173793: XactTrace Single Use Respiratory Effort Belt System (Mar 1, 2019)
- K172703: Disposable Snap Electrode (Nov 13, 2017)
- K163617: REMbrandt (Apr 11, 2017)
- K162140: RemLogic (Dec 1, 2016)
- K153353: Sandman Elite (Jun 23, 2016)
- K122516: Embletta MPR (Feb 21, 2013)
- K111742: Mdrive (Aug 31, 2011)

Source page: https://510kreport.com/company/embla-systems