510(k) · Cleared
ClearedAttachable Cath Lab Hemostasis Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galt Medical Corp. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Dec 2, 2015 as substantially equivalent to K990975 (Merit Medical Systems, Inc., 2000) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Dec 2, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000313 (2000). 4 ancestors in all, the oldest K990975 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
- 2 generations backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
- 1 generation backK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
- This deviceK152528 Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015
- Descendant · cites it directly · 1 of its ownK182660 GaltTWSGalt Medical Corp. · 2019
- Descendant · 2 generations on · 0 of its ownK220280 Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
- Descendant · cites it directly · 0 of its ownK173287 Elite HV RadialGalt Medical Corp. · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | 2000 | 1 |
| −2 | K043525 | Catheter Introducer | Galt Medical Corp. | 2005 | 3 |
| −1 | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer… | Galt Medical | 2012 | 2 |
| 0 (this device) | K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015 | — |
| +1 | K182660 | GaltTWS | Galt Medical Corp. | 2019 | — |
| +2 | K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022 | — |
| +1 | K173287 | Elite HV Radial | Galt Medical Corp. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 DTL? 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? (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 |
|---|---|---|---|
| * | K990975 | IN-Line Hemostasis ValveSummary page 4…(DTL), 21 CFR 870.4290 Device Classification: Class II (Cardiovascular) Predicate Device: Merit Medical IN-LINE Hemostasis Valve (K990975) Galt Medical Cath Lab Introducer Sheath (K043525) Galt VTI® Valved Tearawa… | 2000 |
| * | K043525 | Catheter IntroducerSummary page 4…lass II (Cardiovascular) Predicate Device: Merit Medical IN-LINE Hemostasis Valve (K990975) Galt Medical Cath Lab Introducer Sheath (K043525) Galt VTI® Valved Tearaway Introducer Sheath (K112398) Manufacturer: Galt Medical… | 2005 |
| * | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortSummary page 4…asis Valve (K990975) Galt Medical Cath Lab Introducer Sheath (K043525) Galt VTI® Valved Tearaway Introducer Sheath (K112398) Manufacturer: Galt Medical 2220 Merritt Drive Garland, TX 7504… | 2012 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K182660 (Galt Medical Corp., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.
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/K152528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152528: Attachable Cath Lab Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152528
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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