510(k) · Cleared
ClearedMedline Cardiovascular Procedure Kit
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 Dec 3, 2021 as substantially equivalent to K962826 (Medline Industries, Inc., 1996) after a 136-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 3, 2021
- Review
- 136 days
- Class
- Class II
- Product code
- LRO
- 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 deviceK212258 Medline Cardiovascular Procedure KitMedline Industries, Inc. · 2021
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) | K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | 2021 | — |
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 LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 5…Page 2 of 3 Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 PREDICATE DEVICES K962826 – Medline Radiology-Diagnostic Kits INDICATIONS FOR USE The Medline Cardiovascular Procedure Kit contains a single-use sterile s… | 1996 |
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 LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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) | — |
What is it indicated for?
The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’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/K212258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212258: Medline Cardiovascular Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212258
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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