510(k) Report

510(k) · Cleared

Cleared

Disposable High Pressure Injection Lines with and Without Rotating Adapters

K071196510(k) TraditionalCleared Sep 6, 2007129-day reviewClass II21 CFR 870.1200

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

Coeur, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Sep 6, 2007 as substantially equivalent to K810924 (Medrad, Inc., 1981) and 4 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.

Decided
Sep 6, 2007
Review
129 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K911884 (1994). 5 ancestors in all, the oldest K810924 (1981). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1982: 1 other ancestor1981: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant clearedK911884 · Advance Pressure Monitor/High Pressure Lines · Advance Medical Designs, Inc. · 1994K963749 · High Pressure Injection Lines · Maxxim Medical · 1996K023591 · Ultra High Pressure Injector Lines · Deroyal Industries, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K023591 · Ultra High Pressure Injector Lines · Deroyal Industries, Inc. · 2003K963749 · High Pressure Injection Lines · Maxxim Medical · 1996K911884 · Advance Pressure Monitor/High Pressure Lines · Advance Medical Designs, Inc. · 19940
  1. Root · 3 generations backK911884 Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc. · 1994
  2. 2 generations backK963749 High Pressure Injection LinesMaxxim Medical · 1996
  3. 1 generation backK023591 Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003
  4. This deviceK071196 Disposable High Pressure Injection Lines with and Without Rotating…Coeur, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
  6. Descendant · cites it directly · 0 of its ownK131770 Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015 · cites it directly0descendants
  • K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K911884Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc.1994—
−2K963749High Pressure Injection LinesMaxxim Medical1996—
−1K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc.2003—
0 (this device)K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc.2007—
+1K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd.2015—
+1K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
FIG. 1 — Lineage of K071196, 1994–2015Source: 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), 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 DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (5)

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
*K810924Medrad High Pressure Conecting Tube
Summary page 1
…(21 CFR 870.1200, Product Code DQO) 3. Legally Marketed Devices to which Substantial Equivalence is claimed: Medrad High Pressure Connecting Tube (K8 10924) - Medrad Advance Pressure Monitor/High Pressure Lines (K911884) - Advance Medical Designs, In…
Medrad, Inc.1981—
*K911884Advance Pressure Monitor/High Pressure Lines
Summary page 1
…Substantial Equivalence is claimed: Medrad High Pressure Connecting Tube (K8 10924) - Medrad Advance Pressure Monitor/High Pressure Lines (K911884) - Advance Medical Designs, Inc. Ultra High Pressure Injector Lines (K023591) - DeRoyal Industr…
Advance Medical Designs, Inc.1994—
*K023591Ultra High Pressure Injector Lines
Summary page 1
…Advance Pressure Monitor/High Pressure Lines (K911884) - Advance Medical Designs, Inc. Ultra High Pressure Injector Lines (K023591) - DeRoyal Industries, Inc. flexcil® Contrast Injection Lines (K822 100) - NAMIC High Pressure Line…
Deroyal Industries, Inc.2003—
*K822100High Pressure Contrast Injection Line
Summary page 1
…Advance Medical Designs, Inc. Ultra High Pressure Injector Lines (K023591) - DeRoyal Industries, Inc. flexcil® Contrast Injection Lines (K822 100) - NAMIC High Pressure Lines (K963749) - Maxxim Medical, Inc. 4. Device Description: The Disposable High…
Namic1982—
*K963749High Pressure Injection Lines
Summary page 1
…High Pressure Injector Lines (K023591) - DeRoyal Industries, Inc. flexcil® Contrast Injection Lines (K822 100) - NAMIC High Pressure Lines (K963749) - Maxxim Medical, Inc. 4. Device Description: The Disposable High Pressure Injection Lines with and without Rotating Ad…
Maxxim Medical1996—

Also cleared against K810924: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd.20150
K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd.20140

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?

  • The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K140356 (Sunny Medical Device (Shenzhen) Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K810924.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.

Indications for use as stated in the FDA summary.

Also cleared against K810924

1 other device cites the same predicate.

  • K131517Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013

More from Coeur, Inc.

14 FDA decisions under this applicant name. See the company

  • K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack…Coeur, Inc. · 2017
  • K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016
  • K150902330psi Extension Y-Line with Dual Check ValveCoeur, Inc. · 2015
  • K142745125mL CT SyringeCoeur, Inc. · 2015
  • K140469MR Syringe Dual PackCoeur, Inc. · 2014

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K071196 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071196: Disposable High Pressure Injection Lines with and Without Rotating Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071196

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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