# Kepler Medtec

- Location (FDA's records): Ashland, MA
- FDA decisions: 2 (2010–2011): 2 510(k) clearances
- Product codes: GEI (1), DSA (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 3 (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
- Deroyal Industries, Inc.: 1 (https://510kreport.com/company/deroyal-industries)
- Marquette Medical Systems, Inc.: 1 (https://510kreport.com/company/marquette-medical-systems)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Firms that cite its devices most
- Carefusion 2200, Inc.: 1 (https://510kreport.com/company/carefusion-2200)
- Bipad Surgical, Inc.: 1 (https://510kreport.com/company/bipad-surgical)
- Carefusion 303, Inc.: 1 (https://510kreport.com/company/carefusion-303)

## Its most-cited devices
- K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 (2010), cited by 2
- K110462: Kepler Medtec Disposable Bipolar Cable (2011), cited by 1

## Recent decisions
- K110462: Kepler Medtec Disposable Bipolar Cable (Sep 26, 2011)
- K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 (Aug 11, 2010)

Source page: https://510kreport.com/company/kepler-medtec