# K902274: Customed Cysto Pack I

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Sep 20, 1990 after 122 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1407-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jan 7, 2016 · Class II · Z-1463-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2678-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2558-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2660-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Source page: https://510kreport.com/device/K902274
Methodology: https://510kreport.com/methodology