# Sigma Medical, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 13 (1985–1985): 13 510(k) clearances
- Product codes: CAI (13)
- 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
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)

## Its most-cited devices
- K852316: #3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag (1985), cited by 1

## Recent decisions
- K853065: #6003 Non Conductive Anesthesia Cir W/ Breath Bag (Sep 3, 1985)
- K853344: 4000 Non Conductive Anesthesia Ventilator Circuit (Aug 29, 1985)
- K853343: 3015 Pediatric Non-Conductive Anesthesia Circuit W (Aug 29, 1985)
- K853342: 6013 Non Conductive Anesthesia Circuit W/Breathbag (Aug 29, 1985)
- K852314: #6010 Non-Conductive Ventilator Circuit (Aug 13, 1985)
- K852312: #3005 Pediatric Non-Conduct Anes Cir W/ Brea Bag (Jul 15, 1985)
- K852311: #3002 Pediatric Non-Conduct Anes Cir W/ Brea Bag (Jul 15, 1985)
- K852316: #3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag (Jul 15, 1985)

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