510(k) Report

FDA applicant

Embla Systems

Kanata, CA9 decisions2008–20192 recalls

FDA records 9 decisions for Embla Systems (Kanata, CA) from 2008 to 2019: 9 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and OLZ (Automatic Event Detection Software For…). Since 2016 its 510(k)s took a median of 216 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Embla Systems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Embla Systems’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008: 12011: 12013: 12016: 22017: 22019: 2
2008high 2 (2016) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 12026 (partial year): 1
2008high 1 (2013) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Embla Systems by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Embla Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MNRVentilatory Effort Recorder5decisions
  • OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph3decisions
  • GXYElectrode, Cutaneous1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 216 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122516Embletta MPREmbla Systems · 20133cite it
  • K073682Embletta GoldEmbla Systems, Inc. · 20083cite it
  • K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 20191cites it
  • K153353Sandman EliteEmbla Systems · 20161cites it
  • K111742MdriveEmbla Systems · 20111cites it

What has FDA decided for it lately?

  • K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie…Embla Systems · 2019
  • K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
  • K172703Disposable Snap ElectrodeEmbla Systems · 2017
  • K163617REMbrandtEmbla Systems · 2017
  • K162140RemLogicEmbla Systems · 2016
  • K153353Sandman EliteEmbla Systems · 2016
  • K122516Embletta MPREmbla Systems · 20131 recall
  • K111742MdriveEmbla Systems · 2011

All 8 as Embla Systems →The one decision as Embla Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K122516Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011Sep 29, 2026
  • K073682embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort…Apr 24, 2013Class II