510(k) Report

510(k) · Cleared

Cleared

Compressar Femoral Access Compression Device

K002767510(k) SpecialCleared Sep 27, 200021-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Semler Technologies, Inc. · DXC Clamp, Vascular

Cleared on Sep 27, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.

Decided
Sep 27, 2000
Review
21 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
0

30 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2013: 7 descendants cleared2011: 2 descendants cleared2007: 2 descendants cleared2006: 2 descendants cleared2015: 2 descendants cleared2026: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared2009: 1 descendant cleared2019: 1 descendant cleared2018: 2 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK002767 Compressar Femoral Access Compression DeviceSemler Technologies, Inc. · 2000
  2. Descendant · cites it directly · 17 of its ownK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
  3. Descendant · 2 generations on · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
  4. Descendant · 3 generations on · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
  5. Descendant · 4 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
  6. Descendant · cites it directly · 11 of its ownK102025 Combat Ready ClampCombat Medical Systems, LLC · 2010

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22007: 22009: 12010: 22011: 22013: 72015: 22016: 12018: 22019: 12022: 12023: 22024: 12025: 12026: 1
2004high 7 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all
  • K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004 · cites it directly17descendants
  • K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · 2 generations on16descendants
  • K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · 3 generations on14descendants
  • K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 4 generations on13descendants
  • K102025Combat Ready ClampCombat Medical Systems, LLC · 2010 · cites it directly11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002767Compressar Femoral Access Compression DeviceSemler Technologies, Inc.2000—
+1K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc.2004—
+2K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc.2005—
+3K053300SyvekexcelMarine Polymer Technologies, Inc.2006—
+4K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.2006—
+1K102025Combat Ready ClampCombat Medical Systems, LLC2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200720
200910
201020
201120
201370
201520
201610
201820
201910
202210
202320
202410
202510
202610
FIG. 1 — Lineage of K002767, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (30)

See all 30

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc.200417
K102025Combat Ready ClampCombat Medical Systems, LLC201011

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, K040730 (Vascular Solutions, Inc., 2004) has gone furthest, with 17 descendants of its own.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—
Cite this page

510(k) Report. “K002767: Compressar Femoral Access Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002767

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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