510(k) · Cleared
ClearedRotating Hemostatic Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jan 19, 1988 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 152 devices in its family, counting itself, has a Class I recall. 151 later devices descend from it.
- Decided
- Jan 19, 1988
- Review
- 112 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 0
151 later devices descend from it, 1 citing it directly. 1 of the 152 devices in this family, counting this one, has a Class I recall.
- This deviceK873971 Rotating Hemostatic ValveTarget Therapeutics · 1988
- Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- Descendant · 2 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · 2 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 3 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · 2 generations on · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…7 generations on · 2022
Most influential descendants
Showing 5 of 151 · See all- K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 2 generations on138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 2 generations on105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 3 generations on103descendants
- K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · 2 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873971 | Rotating Hemostatic Valve | Target Therapeutics | 1988 | — |
| +1 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| +2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +2 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +3 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +2 | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi… | Boston Scientific, Target | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 1 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (151)
See all 1511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid… | 1997 | 150 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K971395 (Target Therapeutics, 1997) has gone furthest, with 150 descendants 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.
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) | — |
https://510kreport.com/device/K873971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K873971: Rotating Hemostatic Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873971
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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