510(k) · Cleared
ClearedFogarty-Hydragrip Surgical Clamps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · DXC Clamp, Vascular
Cleared on Aug 18, 1995 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 18, 1995
- Review
- 143 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK951413 Fogarty-Hydragrip Surgical ClampsBaxter Healthcare Corp · 1995
- Descendant · cites it directly · 4 of its ownK974769 Cosgrove ClampAllegiance Healthcare Corp. · 1998
- Descendant · 2 generations on · 1 of its ownK033085 PortaclampCardio Life Research, S.A. · 2004
- Descendant · 2 generations on · 1 of its ownK991589 Flexible Vascular Clamp, Version 2Allegiance Healthcare Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK210324 V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061…Carefusion 2200, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK070380 Portaclamp FlexCardio Life Research, S.A. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974769Cosgrove ClampAllegiance Healthcare Corp. · 1998 · cites it directly4descendants
- K033085PortaclampCardio Life Research, S.A. · 2004 · 2 generations on1descendant
- K991589Flexible Vascular Clamp, Version 2Allegiance Healthcare Corp. · 1999 · 2 generations on1descendant
- K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186Carefusion 2200, Inc. · 2021 · 2 generations on0descendants
- K070380Portaclamp FlexCardio Life Research, S.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951413 | Fogarty-Hydragrip Surgical Clamps | Baxter Healthcare Corp | 1995 | — |
| +1 | K974769 | Cosgrove Clamp | Allegiance Healthcare Corp. | 1998 | — |
| +2 | K033085 | Portaclamp | Cardio Life Research, S.A. | 2004 | — |
| +2 | K991589 | Flexible Vascular Clamp, Version 2 | Allegiance Healthcare Corp. | 1999 | — |
| +2 | K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161… | Carefusion 2200, Inc. | 2021 | — |
| +2 | K070380 | Portaclamp Flex | Cardio Life Research, S.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 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.
Planning a device in DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (6)
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?
- Of its descendants, K974769 (Allegiance Healthcare Corp., 1998) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
https://510kreport.com/device/K951413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951413: Fogarty-Hydragrip Surgical Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951413
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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