510(k) Report

510(k) · Cleared

Cleared

Atraumax Surgical Clamp Model Fog-5048, 75MM Side

K901565510(k) TraditionalCleared Jun 12, 199070-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

Applied Vascular Devices, Inc. · DXC Clamp, Vascular

Cleared on Jun 12, 1990 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 12, 1990
Review
70 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK901565 Atraumax Surgical Clamp Model Fog-5048, 75MM SideApplied Vascular Devices, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK962668 Amr-Acv ClampsApplied Medical Resources · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K962668Amr-Acv ClampsApplied Medical Resources · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901565Atraumax Surgical Clamp Model Fog-5048, 75MM SideApplied Vascular Devices, Inc.1990—
+1K962668Amr-Acv ClampsApplied Medical Resources1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K901565, 1990–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962668Amr-Acv ClampsApplied Medical Resources19960

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, K962668 (Applied Medical Resources, 1996) has gone furthest, with 0 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—

More from Applied Vascular Devices, Inc.

21 FDA decisions under this applicant name. See the company

  • K911730Surgical Obturator with SealApplied Vascular Devices, Inc. · 1991
  • K911589Disposable Surgical Trocar with SealApplied Vascular Devices, Inc. · 1991
  • K910339Avd Intimax Occlusion CatheterApplied Vascular Devices, Inc. · 1991
  • K910372Intimax Thrombectomy CatheterApplied Vascular Devices, Inc. · 19911 recall
  • K911181Intimax (TM) Irrigation CatheterApplied Vascular Devices, Inc. · 1991

Recent decisions in DXC

The DXC category page

  • K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
  • K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences · 2026
  • K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
  • K254060Life Saving TourniquetTW Medical · 2026
  • K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC · 2025

https://510kreport.com/device/K901565 · printed Nov 4, 2026

Cite this page

510(k) Report. “K901565: Atraumax Surgical Clamp Model Fog-5048, 75MM Side.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901565

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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