510(k) Report

FDA applicant

Coapt, LLC

Chicago, IL5 decisions2017–20232 recalls

FDA records 5 decisions for Coapt, LLC (Chicago, IL) from 2017 to 2023: 5 510(k) clearances. All are in product code GXY (Electrode, Cutaneous). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Coapt”.

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

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

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

FDA decisions per year

1in 2023

2017: 12019: 22022: 12023: 1
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2023

2023: 2
2017high 2 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Coapt, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXYElectrode, Cutaneous5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K162891Complete Control SystemCoapt, LLC · 20172cite it
  • K191083COMPLETE CONTROL System Gen2Coapt, LLC · 20191cites it
  • K190416Dome ElectrodeCoapt, LLC · 20191cites it
  • K223738Alpha Control Liner System (ACLS)Coapt · 20231cites it

What has FDA decided for it lately?

  • K223738Alpha Control Liner System (ACLS)Coapt · 2023
  • K223605ControlSeal Electrode (ELSB)Coapt · 20221 recall
  • K191083COMPLETE CONTROL System Gen2Coapt, LLC · 2019
  • K190416Dome ElectrodeCoapt, LLC · 20191 recall
  • K162891Complete Control SystemCoapt, LLC · 2017

All 3 as Coapt, LLC →All 2 as Coapt →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K223605Coapt ControlSeal Electrode, cutaneous EMG ElectrodeOct 2, 2023Class II
  • K190416Coapt Dome Electrode, Gen2 system, cutaneous electrodeOct 2, 2023Class II

Other applicant names beginning “Coapt”

FDA records each applicant name separately; these may or may not be the same firm.

Coapt Systems, Inc. 17