510(k) · Cleared
Recalled · Class II · 2026Medline Radiology-Diagnostic Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LRO General Surgery Tray
Cleared on Sep 16, 1996 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 16, 1996
- Review
- 59 days
- Class
- Class II
- Product code
- LRO
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK962826 Medline Radiology-Diagnostic KitsMedline Industries, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK212258 Medline Cardiovascular Procedure KitMedline Industries, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK965112 Medline Catheterization Laboratory Trays/Kits/PacksMedline Industries, Inc. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962826 | Medline Radiology-Diagnostic Kits | Medline Industries, Inc. | 1996 | — |
| +1 | K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | 2021 | — |
| +1 | K965112 | Medline Catheterization Laboratory Trays/Kits/Packs | Medline Industries, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2026 | Class II | Z-2101-2026 | Process control | 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, the identified calibration issues… |
| Feb 11, 2025 | Class II | Z-1444-2025 | Under Investigation by firm | 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 patient health. |
| Apr 8, 2024 | Class II | Z-3025-2024 | Under Investigation by firm | 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 patient health. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K212258 (Medline Industries, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
https://510kreport.com/device/K962826 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962826: Medline Radiology-Diagnostic Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962826
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026