# K950295: Wound Closure/Laceration Tray

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Apr 18, 1995 after 84 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 14 (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-1436-2016: 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-1422-2016: 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-1424-2016: 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-1414-2016: 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-1406-2016: 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-1405-2016: 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-1415-2016: 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-2556-2015: 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-2609-2015: 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-2557-2015: 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-2584-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Dec 8, 2011 · Not classified · Z-1260-2012: The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condit
- Dec 8, 2011 · Not classified · Z-1261-2012: The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condit
- Dec 8, 2011 · Not classified · Z-1262-2012: The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condit

Source page: https://510kreport.com/device/K950295
Methodology: https://510kreport.com/methodology