# Xeridiem Medical Devices, A Spectrum Plastics Group Company

- Location (FDA's records): Tucson, AZ
- FDA decisions: 2 (2018–2023): 2 510(k) clearances
- Product codes: PIF (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Xeridiem Medical Devices: 1 (https://510kreport.com/company/xeridiem-medical-devices)

## Its most-cited devices
- K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit (2018), cited by 1

## Recent decisions
- K232046: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (Oct 6, 2023)
- K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit (Oct 18, 2018)

Source page: https://510kreport.com/company/xeridiem-medical-devices-a-spectrum-plastics-group