# K962652: Urinary Drainage Bag, (Reorder NO. 0749 - Product NO. 900-749)

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Oct 4, 1996 after 88 days
- Product code: KNX (Collector, Urine, (And Accessories) For Indwelling Catheter)
- Device class: 2
- Regulation: 21 CFR 876.5250
- Recalls of this device: 11 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1425-2016: 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-1413-2016: 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-1428-2016: 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-1412-2016: 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-1434-2016: 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-2607-2015: 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-2585-2015: 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-2566-2015: 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-2591-2015: 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-2592-2015: 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-2567-2015: 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/K962652
Methodology: https://510kreport.com/methodology