# Shape Medical Systems, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 2 (2009–2016): 2 510(k) clearances
- Product codes: BTY (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Erich Jaeger, Inc.: 1 (https://510kreport.com/company/erich-jaeger)
- Cortex Biophysik GmbH: 1 (https://510kreport.com/company/cortex-biophysik)

## Firms that cite its devices most
- Treymed, Inc.: 1 (https://510kreport.com/company/treymed)

## Its most-cited devices
- K090722: Shape-HF Cardiopulmonary Exercise Testing System (2009), cited by 2

## Recent decisions
- K150888: Shape-HF Cardiopulmonary Testing System (Jan 21, 2016)
- K090722: Shape-HF Cardiopulmonary Exercise Testing System (Mar 31, 2009)

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