# Burditt & Calkins-Siemens-Elema

- Location (FDA's records): Mchenry, IL
- FDA decisions: 10 (1976–1984): 10 510(k) clearances
- Product codes: DXY (2), KRB (1), DSB (1), BTY (1), FLL (1), HGY (1), BYJ (1), DTB (1), FAE (1)
- 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
- Philips Electronics UK Limited: 1 (https://510kreport.com/company/philips-electronics-uk)

## Its most-cited devices
- K823591: Ameda Hand Breast Pump (1982), cited by 1

## Recent decisions
- K833519: Pulse Generator Model 688 (Jan 30, 1984)
- K833155: Rayden Medical Mini Pulse Volume Record (Jan 26, 1984)
- K830344: Siemens-Elma Pulse Generator #718 (May 27, 1983)
- K823435: Mon-a-Therm Myocardial Temp. Sensor (Dec 30, 1982)
- K823591: Ameda Hand Breast Pump (Dec 28, 1982)
- K822239: Coaxial Bipolar Pacing Electrode (Oct 4, 1982)
- K821712: Informed Remote Field Unit Model IFM1000 (Jul 26, 1982)
- K803111: Erectaid (Jan 23, 1981)

Source page: https://510kreport.com/company/burditt-calkins-siemens-elema
