510(k) · Cleared
ClearedKaplan-Simpson InfusaSleeve II Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Localmed, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jun 28, 1995 as substantially equivalent to K950615 (Localmed, Inc., 1995) after a 42-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jun 28, 1995
- Review
- 42 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950615 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK950615 Kaplan-Simpson Infusasleeve CatheterLocalmed, Inc. · 1995
- This deviceK952317 Kaplan-Simpson InfusaSleeve II CatheterLocalmed, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999
Most influential descendants
Showing 1 of 1 · See all- K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950615 | Kaplan-Simpson Infusasleeve Catheter | Localmed, Inc. | 1995 | — |
| 0 (this device) | K952317 | Kaplan-Simpson InfusaSleeve II Catheter | Localmed, Inc. | 1995 | — |
| +1 | K983039 | Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee… | Schneider/Namic | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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 QEY? 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 QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K950615 | Kaplan-Simpson Infusasleeve CatheterSummary page 4…he following is a summary of the characteristics comparison chart with the predicate device (InfusaSleeve): LOCALMED™ InfusaSleeve™ 1l LOCALMED™ InfusaSleeve™ Catheter (K950615) Catheter Intended Use General Indications: General intravascular use, delivery General intravascular use, delivery of of ther… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983039 | Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion… | 1999 | 0 |
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?
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, 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 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Kaplan-Simpson InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.
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/K952317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952317: Kaplan-Simpson InfusaSleeve II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952317
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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