# Gkc Manufacturing Pty, Ltd.

- Location (FDA's records): Melbourne, AU
- FDA decisions: 3 (2014–2022): 3 510(k) clearances
- Product codes: GYD (3)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Axon Instruments, Inc.: 1 (https://510kreport.com/company/axon-instruments)
- Cleveland Medical Devices, Inc.: 1 (https://510kreport.com/company/cleveland-medical-devices)
- Actigraph, LLC: 1 (https://510kreport.com/company/actigraph)
- Vocel: 1 (https://510kreport.com/company/vocel)

## Firms that cite its devices most
- New Touch Digital, Inc.: 1 (https://510kreport.com/company/new-touch-digital)
- Rune Labs, Inc.: 1 (https://510kreport.com/company/rune-labs)
- Empatica S.r.l.: 1 (https://510kreport.com/company/empatica)

## Its most-cited devices
- K140086: Personal Kinetigraph (PKG) System (2014), cited by 2
- K161717: Personal Kinetigraph (PKG) System (2016), cited by 2
- K211887: Personal Kinetigraph (PKG) System Gen 2 Plus (2022), cited by 1

## Recent decisions
- K211887: Personal Kinetigraph (PKG) System Gen 2 Plus (Mar 11, 2022)
- K161717: Personal Kinetigraph (PKG) System (Sep 20, 2016)
- K140086: Personal Kinetigraph (PKG) System (Aug 22, 2014)

Source page: https://510kreport.com/company/gkc-manufacturing