# Mallinckrodt Sensor Systems, Inc.

- Location (FDA's records): Ann Arbor, MI
- FDA decisions: 2 (1991–1996): 2 510(k) clearances
- Product codes: JGS (1), CHL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sendx Medical, Inc.: 1 (https://510kreport.com/company/sendx-medical)

## Its most-cited devices
- K910305: Gem-Premier System (1991), cited by 1

## Recent decisions
- K961335: Gem Premier Plus Model 5500 (Jun 28, 1996)
- K910305: Gem-Premier System (Apr 3, 1991)

Source page: https://510kreport.com/company/mallinckrodt-sensor-systems