510(k) Report

510(k) · Cleared

Cleared

Rmi Internal Mammary Artery Cannula

K960098510(k) TraditionalCleared Mar 26, 199675-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

Research Medical, Inc. · DQR Cannula, Catheter

Cleared on Mar 26, 1996 after a 75-day review. The FDA summary names its predicate without a number.

Decided
Mar 26, 1996
Review
75 days
Class
Class II
Product code
DQR
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K960098Source: FDA 510(k) database · 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—DLP I.M.A. Cannula, Code #31001
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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.

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 Research Medical, Inc.

35 FDA decisions under this applicant name. See the company

  • K970739Rmi Hemoconcentrator Preference PackResearch Medical, Inc. · 1997
  • K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
  • K961927Rmi Hemoconcentractor Tubing SetResearch Medical, Inc. · 1996
  • K951344Rmi HemoconcentratorResearch Medical, Inc. · 1995
  • K922083Rmi Surgiccal Site Visualization WandResearch Medical, Inc. · 1993

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
  • K902674Datascope Arterial Cannula W/Access PortDatascope Corp. · 1991

https://510kreport.com/device/K960098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960098: Rmi Internal Mammary Artery Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960098

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026