# Sibel Health, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: DRG (2), DQA (1), MSX (1), HGM (1)
- 510(k) review time since 2016: median 121 days, against 249 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 5 (3 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
- Taiwan Aulisa Medical Devices Technologies, Inc.: 1 (https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Huntleigh Healthcare, Inc.: 1 (https://510kreport.com/company/huntleigh-healthcare)
- Sibel, Inc.: 1 (https://510kreport.com/company/sibel)

## Firms that cite its devices most
- Iorbit Digital Technologies Private Limited: 2 (https://510kreport.com/company/iorbit-digital-technologies-private)

## Its most-cited devices
- K223711: ANNE One (2023), cited by 4
- K242842: ANNE View, Central Hub (2025), cited by 1

## Recent decisions
- K253021: ANNE Maternal (Feb 26, 2026)
- K242842: ANNE View, Central Hub (Jan 8, 2025)
- K240251: ANNE Chest (Jun 3, 2024)
- K240305: ANNE Limb (May 28, 2024)
- K223711: ANNE One (Aug 10, 2023)

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