# Coapt, LLC

- Location (FDA's records): Chicago, IL
- FDA decisions: 5 (2017–2023): 5 510(k) clearances
- Names in FDA's records: Coapt, LLC (3); Coapt (2)
- Product codes: GXY (5)
- 510(k) review time since 2016: median 30 days, against 113 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 5 (3 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
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Otto Bock, Austria GmbH: 1 (https://510kreport.com/company/otto-bock-austria)

## Firms that cite its devices most
- Infinite Biomedical Technologies, LLC: 1 (https://510kreport.com/company/infinite-biomedical-technologies)
- Bionit Labs Srl: 1 (https://510kreport.com/company/bionit-labs)

## Its most-cited devices
- K162891: Complete Control System (2017), cited by 2
- K191083: COMPLETE CONTROL System Gen2 (2019), cited by 1
- K190416: Dome Electrode (2019), cited by 1
- K223738: Alpha Control Liner System (ACLS) (2023), cited by 1

## Recent decisions
- K223738: Alpha Control Liner System (ACLS) (Jan 11, 2023)
- K223605: ControlSeal Electrode (ELSB) (Dec 30, 2022)
- K191083: COMPLETE CONTROL System Gen2 (May 24, 2019)
- K190416: Dome Electrode (Apr 4, 2019)
- K162891: Complete Control System (Apr 14, 2017)

Source page: https://510kreport.com/company/coapt