# Blue Sky Medical Group Incorporated

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 4 (2004–2007): 4 510(k) clearances
- Product codes: OMP (4)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 22 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Firms that cite its devices most
- Talley Medical: 3 (https://510kreport.com/company/talley-medical)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Boehringer Laboratories: 2 (https://510kreport.com/company/boehringer-laboratories)
- Atmos, Inc.: 1 (https://510kreport.com/company/atmos)
- Novaspine, LLC: 1 (https://510kreport.com/company/novaspine)
- Accuro Medical Products, LLC: 1 (https://510kreport.com/company/accuro-medical-products)
- Simex Medizintechnik GmbH: 1 (https://510kreport.com/company/simex-medizintechnik)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Its most-cited devices
- K042134: Versatile 1 Wound Vacuum System (2004), cited by 10
- K052456: Modification to Versatile 1 Wound Vacuum System (2005), cited by 6
- K061919: Versatile 1 Ezcare Wound Vacuum System (2007), cited by 3
- K061367: Bluesky Vista Wound Vacuum System, Model 100.0500 (2006), cited by 3

## Recent decisions
- K061919: Versatile 1 Ezcare Wound Vacuum System (Feb 5, 2007)
- K061367: Bluesky Vista Wound Vacuum System, Model 100.0500 (Aug 10, 2006)
- K052456: Modification to Versatile 1 Wound Vacuum System (Nov 4, 2005)
- K042134: Versatile 1 Wound Vacuum System (Nov 1, 2004)

Source page: https://510kreport.com/company/blue-sky-medical-group