510(k) · Decided
DecidedMedline Catheterization Laboratory Trays/Kits/Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 10, 1997 as substantially equivalent to K962826 (Medline Industries, Inc., 1996) after a 294-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 10, 1997
- Review
- 294 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962826 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962826 Medline Radiology-Diagnostic KitsMedline Industries, Inc. · 1996 · Recalled
- This deviceK965112 Medline Catheterization Laboratory Trays/Kits/PacksMedline Industries, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962826 | Medline Radiology-Diagnostic Kits | Medline Industries, Inc. | 1996 | 3 |
| 0 (this device) | K965112 | Medline Catheterization Laboratory Trays/Kits/Packs | Medline Industries, Inc. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962826 | Medline Radiology-Diagnostic KitsSummary page 2…nd, VA. We are unable to locate 510(k)s for this category of kits for either manufacturer, however, Medline Industries, Inc. has approved 510(k)’s for similar kits under K962826. SeRviCeg. - %, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service § WIALTY & ° 44, & Tese Food an… | 1996 |
| * | — | Baxter Healthcare procedure-specific kits Named without a submission number | |
| * | — | Sterile Concepts procedure-specific kits Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K962826.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
Medline Catheterization Laboratory Trays/Kits/Packs are intended for use by licensed physicians.
The intended use of the medical products assembled in these kits will not be changed from the marufacturer’s original intended use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965112: Medline Catheterization Laboratory Trays/Kits/Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026