510(k) Report

510(k) · Cleared

Cleared

New Model Styles for Aortic Arch Cannula

K870825510(k) TraditionalCleared Mar 23, 198720-day reviewClass II21 CFR 870.1300

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

Shiley, Inc. · DQR Cannula, Catheter

Cleared on Mar 23, 1987 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 23, 1987
Review
20 days
Class
Class II
Product code
DQR
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK870825 New Model Styles for Aortic Arch CannulaShiley, Inc. · 1987
  2. Descendant · cites it directly · 1 of its ownK162215 Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L. · 2017
  3. Descendant · 2 generations on · 0 of its ownK180979 PureFlex Arterial CannulaeSorin Group Italia S.R.L. · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L. · 2017 · cites it directly1descendant
  • K180979PureFlex Arterial CannulaeSorin Group Italia S.R.L. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870825New Model Styles for Aortic Arch CannulaShiley, Inc.1987—
+1K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L.2017—
+2K180979PureFlex Arterial CannulaeSorin Group Italia S.R.L.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
FIG. 1 — Lineage of K870825, 1987–2018Source: 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 DQR? 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
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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? (2)

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

NumberDeviceApplicantDecidedDescendants
K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L.20171

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, K162215 (Sorin Group Italia S.R.L., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQR devices

DQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQR

1in 2013

2008: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQR

Too few DQR 510(k)s in any year since 2007 to give a median.

Recalls per year · DQR

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · DQR

6in 2025

2007: 172008: 82009: 272010: 242011: 72012: 72013: 62014: 82015: 402016: 752017: 292018: 172019: 162020: 42021: 112022: 272023: 362024: 72025: 6
2007high 75 (2016) · low 4 (2020)2025

MAUDE reports naming product code DQR, 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
20070—017
20081—08
20090—027
20100—024
20110—07
20120—07
20131—06
20140—08
20150—040
20160—075
20170—029
20180—017
20190—016
20200—14
20210—011
20220—027
20230—036
20240—07
20250—06
20260—0—

More from Shiley, Inc.

180 FDA decisions under this applicant name. See the company

  • K920594Shiley Perfusion Tubing SetsShiley, Inc. · 1993
  • K910991Shiley Therapeutic Autotransfusion SystemShiley, Inc. · 1991
  • K911876Shiley Plexus (R) Venous Reservoir, PVR1200Shiley, Inc. · 1991
  • K910923BCD AdvancedShiley, Inc. · 1991
  • K901548Biomedical Sensors-Shiley BGM 4000 Intra Blood GasShiley, Inc. · 1991

Recent decisions in DQR

The DQR category page

  • K131446Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation · 2013
  • K07355918 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IIEdwards Lifesciences Research Medical · 20082 Class I recalls
  • K051655Angiodynamics, Inc., Micro Access KitsAngioDynamics, Inc. · 20059 recalls
  • K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
  • K960098Rmi Internal Mammary Artery CannulaResearch Medical, Inc. · 1996

https://510kreport.com/device/K870825 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870825: New Model Styles for Aortic Arch Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870825

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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