510(k) Report

510(k) · Cleared

Cleared

Origen Dual Lumen Catheter

K003288510(k) TraditionalCleared Jun 8, 2001231-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

Origen Biomedical, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Jun 8, 2001 after a 231-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 44 later devices descend from it.

Decided
Jun 8, 2001
Review
231 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

44 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2014: 4 descendants cleared2013: 1 descendant cleared2023: 2 descendants cleared2017: 2 descendants cleared2005: 1 descendant cleared2016: 4 descendants cleared2021: 3 descendants cleared2018: 5 descendants cleared2012: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2026: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
  2. Descendant · cites it directly · 19 of its ownK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
  3. Descendant · cites it directly · 19 of its ownK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
  4. Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  5. Descendant · 2 generations on · 17 of its ownK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
  6. Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12006: 12007: 22008: 42010: 12011: 12012: 22013: 12014: 42016: 42017: 22018: 52020: 22021: 32022: 12023: 22024: 22025: 12026: 2
2003high 5 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 44 · See all
  • K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRAvalon Laboratories, LLC · 2008 · cites it directly19descendants
  • K031485Rinspiration SystemKerberos Proximal Solutions · 2003 · cites it directly19descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
  • K041291Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003288Origen Dual Lumen CatheterOrigen Biomedical, Inc.2001—
+1K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR…Avalon Laboratories, LLC2008—
+1K031485Rinspiration SystemKerberos Proximal Solutions2003—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+2K041291Rinspiration SystemKerberos Proximal Solutions, Inc.2004—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200610
200720
200840
201010
201110
201220
201310
201440
201640
201720
201850
202020
202130
202210
202320
202420
202510
202620
FIG. 1 — Lineage of K003288, 2001–2026Source: 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 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (44)

See all 44

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

NumberDeviceApplicantDecidedDescendants
K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRAvalon Laboratories, LLC200819
K031485Rinspiration SystemKerberos Proximal Solutions200319
K080700Duoflo CatheterThermopeutix, Inc.20083

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, K081820 (Avalon Laboratories, LLC, 2008) has gone furthest, with 19 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

More from Origen Biomedical, Inc.

4 FDA decisions under this applicant name. See the company

  • K113869Origen Reinforced Dual Lumen CatheterOrigen Biomedical, Inc. · 20129 Class I recalls
  • K021702Cryobag, Model CBOrigen Biomedical, Inc. · 2002
  • K003145Origen Bladder HolderOrigen Biomedical, Inc. · 2001

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/K003288 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003288: Origen Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003288

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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