# Engineered Custom Mfg., Inc.

- Location (FDA's records): Ridgefield, NJ
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: KCT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sterile Containment Technology, LLC: 1 (https://510kreport.com/company/sterile-containment-technology)
- Case Medical, Inc.: 1 (https://510kreport.com/company/case-medical)

## Its most-cited devices
- K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) (1997), cited by 2

## Recent decisions
- K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) (May 6, 1997)

Source page: https://510kreport.com/company/engineered-custom-mfg