# Sibel, Inc.

- Location (FDA's records): Niles, IL
- FDA decisions: 3 (2021–2022): 3 510(k) clearances
- Product codes: DRG (2), MNR (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 3 (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
- Itamar Medical, Ltd.: 1 (https://510kreport.com/company/itamar-medical)
- Isansys Lifecare, Ltd.: 1 (https://510kreport.com/company/isansys-lifecare)

## Firms that cite its devices most
- Huxley Medical: 1 (https://510kreport.com/company/huxley-medical)
- Sibel Health, Inc.: 1 (https://510kreport.com/company/sibel-health)

## Its most-cited devices
- K211305: ANNE One (2021), cited by 2
- K220095: ANNE Sleep (2022), cited by 1

## Recent decisions
- K221530: ANNE Pediatric (Nov 22, 2022)
- K220095: ANNE Sleep (Jul 11, 2022)
- K211305: ANNE One (Sep 14, 2021)

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