# Sigma

- Location (FDA's records): St. Louis, MO
- FDA decisions: 6 (1983–1997): 6 510(k) clearances
- Product codes: FRN (3), KIT (2), LXM (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (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 whose devices it cites most
- Sense Technology, Inc.: 1 (https://510kreport.com/company/sense-technology)

## Firms that cite its devices most
- Spinal Acoustics, LLC: 1 (https://510kreport.com/company/spinal-acoustics)
- Advanced Spinal Technologies, Inc.: 1 (https://510kreport.com/company/advanced-spinal-technologies)

## Its most-cited devices
- K962239: Smart Adjuster (SA201) (1997), cited by 2

## Recent decisions
- K962239: Smart Adjuster (SA201) (Jan 10, 1997)
- K926191: Sigma 7000 and SIGMA70002 (Aug 31, 1993)
- K851738: MCDB-105 Med. M6395, W/L-Glutamine, 25M M Herpes & (May 15, 1985)
- K851737: MCDB-110 Med. M6520 W/L-Glutamine-25M M Herpes & (May 15, 1985)
- K820038: SIGMA 7000 (Jan 26, 1983)
- K830038: Sigma 7000-6000 Infusion Pumps (Jan 26, 1983)

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