510(k) · Cleared
ClearedEZ Hold 1 LBS., EZ Hold 2 LBS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · DXC Clamp, Vascular
Cleared on Jan 12, 1998 after a 144-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 144 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK973132 EZ Hold 1 LBS., EZ Hold 2 LBSTz Medical, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · 2 generations on · 5 of its ownK072890 Stasilon FREntegrion, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · cites it directly14descendants
- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 2 generations on13descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 3 generations on5descendants
- K072890Stasilon FREntegrion, Inc. · 2007 · 2 generations on5descendants
- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973132 | EZ Hold 1 LBS., EZ Hold 2 LBS | Tz Medical, Inc. | 1998 | — |
| +1 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +2 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| +3 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +2 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| +3 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 162 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, K053300 (Marine Polymer Technologies, Inc., 2006) has gone furthest, with 14 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 | — |
What is it indicated for?
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps but is held in place by the technician until hemostasis is obtained. The EZ Hold is: 1) designed…
Read the full statement (145 words)
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps but is held in place by the technician until hemostasis is obtained.
The EZ Hold is: 1) designed to reduce the risk for the RN of direct prolonged contact with body fluids (blood), and 2) alleviate bio-mechanical stress which occurs during traditional digital compression of the femoral artery post-cardiac catheritization. The devices work with currently marketed compatible pressure disks (DisCo PNO-R or PNO-1 or equivalent ball and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973132: EZ Hold 1 LBS., EZ Hold 2 LBS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973132
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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