# Custom Pack Reliability

- Location (FDA's records): Orlando, FL
- FDA decisions: 21 (1996–1996): 21 510(k) clearances
- Product codes: FRG (7), FCM (2), GAW (1), FAQ (1), KYZ (1), BYY (1), MLS (1), KKX (1), GDY (1), JOL (1), BTO (1), GCX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K960205: CPR Tracheotomy Care Tray (Aug 27, 1996)
- K960243: CPR C-Section Delivery Pack (May 23, 1996)
- K960239: CPR D & C Tray (May 23, 1996)
- K960216: CPR Suction Catheter Kit (Apr 15, 1996)
- K960213: CPR Total Hip Pack (Apr 12, 1996)
- K960211: CPR Total Knee Pack (Apr 12, 1996)
- K960210: CPR Ortho Hand Pack (Apr 12, 1996)
- K960206: CPR Dressing Change Tray (Apr 12, 1996)

Source page: https://510kreport.com/company/custom-pack-reliability