# Customed, Inc.

- Location (FDA's records): Fajardo, PR
- FDA decisions: 37 (1990–2026): 37 510(k) clearances
- Names in FDA's records: Customed, Inc. (36); CustoMED , Ltd. (1)
- Product codes: KKX (11), LRO (6), HHD (3), FCM (2), LRS (2), KYZ (1), MCZ (1), CBT (1), FRG (1), GJE (1), HFC (1), KNX (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 107 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Angiosystems, Inc.: 1 (https://510kreport.com/company/angiosystems)
- Materialise NV: 1 (https://510kreport.com/company/materialise)

## Recent decisions
- K260116: CustoMED Viewer (Jun 3, 2026)
- K974647: Fanfold Drape 41 X 57 Product NO. 900-633, Recorder NO. 0633 (Jan 5, 1998)
- K971920: Gown Poly Reinforced Large (Product NO.900-522)/(Reorder NO. 0522) (Dec 4, 1997)
- K964011: Suction Catheter Tray Product NO. 900277 (Nov 25, 1996)
- K962652: Urinary Drainage Bag, (Reorder NO. 0749 - Product NO. 900-749) (Oct 4, 1996)
- K962596: Customed Blood Extraction Kit (Sep 27, 1996)
- K961442: Universal Drainage Tray (May 9, 1996)
- K953678: Sterimed Sterization Wrapper (Non-Sterile) (Oct 2, 1995)

Source page: https://510kreport.com/company/customed