# K962826: Medline Radiology-Diagnostic Kits

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 16, 1996 after 59 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K212258: Medline Cardiovascular Procedure Kit (2021), 0 descendants of its own
- K965112: Medline Catheterization Laboratory Trays/Kits/Packs (1997), 0 descendants of its own

## Recalls of this device
- Jan 7, 2026 · Class II · Z-2101-2026: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however,
- Feb 11, 2025 · Class II · Z-1444-2025: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to pati
- Apr 8, 2024 · Class II · Z-3025-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat

Source page: https://510kreport.com/device/K962826
Methodology: https://510kreport.com/methodology