# Sigma Intl.

- Location (FDA's records): Medina, NY
- FDA decisions: 3 (1994–2004): 3 510(k) clearances
- Product codes: FRN (3)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 18 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alaris Medical Systems, Inc.: 1 (https://510kreport.com/company/alaris-medical-systems)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Sigma Intl. General Medical Apparatus, Inc.: 1 (https://510kreport.com/company/sigma-intl-general-medical-apparatus)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Firms that cite its devices most
- Q Core Medical, Ltd.: 1 (https://510kreport.com/company/q-core-medical)
- Delphi Medical Systems: 1 (https://510kreport.com/company/delphi-medical-systems)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K042121: Spectrum and Spectrum with Master Drug Library (2004), cited by 3

## Recent decisions
- K042121: Spectrum and Spectrum with Master Drug Library (Aug 26, 2004)
- K962709: Sigma Syringe Delivery System (Multi-Doser Rev. 1/Multi-Doser Rev. II/Single-Doser Rev. 1-10/Single-Doser Rev. 1-20/ (Oct 7, 1996)
- K942162: Sigma 8000 and Sigma 8002 (Oct 20, 1994)

Source page: https://510kreport.com/company/sigma-intl