510(k) Report

510(k) · Cleared

Recalled · 2006

Cobe Optimin Hollow Fiber Membrane Oxygenator

K991452510(k) TraditionalCleared Oct 7, 1999164-day reviewClass II21 CFR 870.4350Recalls 2

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

Cobe Cardiovascular, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass

Cleared on Oct 7, 1999 as substantially equivalent to K963518 (Cobe Cardiovascular, Inc., 1997) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 1996. 19 later devices descend from it. It has been recalled 2 times.

Decided
Oct 7, 1999
Review
164 days
Class
Class II
Product code
DTZ
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K960074 (1996). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2001: 1 descendant cleared2005: 2 descendants cleared2012: 2 descendants cleared2015: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant cleared2026: 3 descendants cleared2021: 3 descendants cleared2020: 2 descendants cleared2022: 1 descendant clearedK960074 · Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir · Terumo Medical Corp. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 5 descendants K960074 · Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir · Terumo Medical Corp. · 19960
  1. Root · 1 generation backK960074 Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous…Terumo Medical Corp. · 1996
  2. This deviceK991452 Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 1999
  3. Descendant · cites it directly · 17 of its ownK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK120185 Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter…Sorin Group Italia S.R.L. · 2012
  5. Descendant · 3 generations on · 5 of its ownK180448 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber…Sorin Group Italia S.R.L. · 2018
  6. Descendant · 2 generations on · 5 of its ownK150489 EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L. · 2015
  7. Descendant · 3 generations on · 1 of its ownK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2001: 12005: 22008: 12012: 22013: 12015: 12018: 12020: 22021: 32022: 12025: 12026: 3
2001high 3 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 19 · See all
  • K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L. · 2005 · cites it directly17descendants
  • K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · 2 generations on8descendants
  • K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2018 · 3 generations on5descendants
  • K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L. · 2015 · 2 generations on5descendants
  • K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L · 2021 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960074Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous ReservoirTerumo Medical Corp.1996—
0 (this device)K991452Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc.1999—
+1K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy…Dideco S.R.L.20051
+2K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and…Sorin Group Italia S.R.L.2012—
+3K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with…Sorin Group Italia S.R.L.2018—
+2K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.2015—
+3K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood…Qura S.R.L2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200520
200810
201220
201310
201510
201810
202020
202130
202210
202510
202630
FIG. 1 — Lineage of K991452, 1996–2026Source: 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), 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 DTZ? 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 DTZ device

  1. #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 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? (2)

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
*K963518Cobe Optima XP Hollow Fiber Membrane Oxygenator
Summary page 2
…COMPARISON The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is substantially equivalent to the currently marketed COBE® Optima XP™ Hollow Fiber Membrane Oxygenator (K963518). The COBE® Optimin™ Oxygenator has a lower priming volume and is rated for lower blood and gas flow rates than the COBE® Optima…
Cobe Cardiovascular, Inc.19972
*K960074Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir
Summary page 2
…XP™ Oxygenator is for adult patients. The COBE® Optimin™ Oxygenator is substantially equivalent to the currently marketed Terumo® Capiox® SX 10 Hollow Fiber Oxygenator (K960074). Specifications for the two devices are comparable and they are substantially equivalent in features and intended use. Substant…
Terumo Medical Corp.1996—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L.200517
K013480Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc.20010

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 26, 2006Not classifiedZ-1424-06OtherCooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the…
Jun 26, 2006Not classifiedZ-1427-06OtherCooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K043323 (Dideco S.R.L., 2005) has gone furthest, with 17 descendants of its own.

How does its category compare?

All DTZ devices

DTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTZ

2in 2025

2007: 42008: 32009: 92010: 22011: 42012: 92013: 92014: 52015: 92016: 32017: 22018: 32019: 52020: 52021: 52022: 22023: 52024: 32025: 22026 (partial year): 3
2007high 9 (2009) · low 2 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTZ

124in 2024

2007: 55 days median2008: 88 days median2009: 210 days median2011: 160 days median2012: 90 days median2013: 28 days median2014: 28 days median2015: 134 days median2016: 62 days median2018: 72 days median2019: 90 days median2020: 93 days median2021: 336 days median2023: 145 days median2024: 124 days median2026 (partial year): 137 days median
2007high 336 (2021) · low 28 (2013)2026

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

Recalls per year · DTZ

1in 2025

2007: 72008: 52010: 12011: 132012: 142014: 22016: 12018: 2, 2 Class I2019: 12020: 32021: 1, 1 Class I2022: 62025: 1
2007high 14 (2012) · low 0 (2009)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DTZ

976in 2025

2007: 1342008: 1052009: 522010: 1192011: 1902012: 2152013: 3462014: 7642015: 6582016: 4432017: 3882018: 3202019: 4892020: 4422021: 5952022: 5592023: 7382024: 5352025: 976
2007high 976 (2025) · low 52 (2009)2025

MAUDE reports naming product code DTZ, 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
20074557134
20083885105
20099210052
20102—1119
2011416013190
201299014215
20139280346
20145282764
201591340658
20163621443
20172—0388
20183722 (2)320
20195901489
20205933442
202153361 (1)595
20222—6559
202351450738
202431240535
20252—1976
202631370—

What is it indicated for?

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Cobe Cardiovascular, Inc.

43 FDA decisions under this applicant name. See the company

  • K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
  • K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
  • K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc. · 2004
  • K033641Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800Cobe Cardiovascular, Inc. · 2003
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 20031 recall

Recent decisions in DTZ

The DTZ category page

  • K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
  • K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026
  • K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3…Spectrum Medical S.R.L. · 2026
  • K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus…Eurosets S.R.L · 2025
  • K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025

https://510kreport.com/device/K991452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991452: Cobe Optimin Hollow Fiber Membrane Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991452

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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