510(k) Report

510(k) · Cleared

Cleared

Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800

K980786510(k) TraditionalCleared Aug 24, 1998175-day reviewClass II21 CFR 870.4400

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

Cobe Cardiovascular, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Aug 24, 1998 after a 175-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Aug 24, 1998
Review
175 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2011: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980786 Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and…Cobe Cardiovascular, Inc. · 1998
  2. Descendant · cites it directly · 5 of its ownK050111 Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
  3. Descendant · 2 generations on · 2 of its ownK112771 BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011
  4. Descendant · 2 generations on · 1 of its ownK070605 Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG · 2008
  5. Descendant · 3 generations on · 0 of its ownK223361 BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  6. Descendant · 3 generations on · 0 of its ownK161733 Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L. · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12009: 12011: 12017: 12023: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005 · cites it directly5descendants
  • K112771BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011 · 2 generations on2descendants
  • K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on1descendant
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023 · 3 generations on0descendants
  • K161733Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980786Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800Cobe Cardiovascular, Inc.1998—
+1K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc.2005—
+2K112771BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L.2011—
+2K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG2008—
+3K223361BMR 1900 PhisioSorin Group Italia S.R.L.2023—
+3K161733Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
200910
201110
201710
202310
FIG. 1 — Lineage of K980786, 1998–2023Source: 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 DTN? 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 DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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? (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
*—COBE® VRB® 1200™ Closed Venous Reservoir Bag
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc.20055

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, K050111 (Cobe Cardiovascular, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

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

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

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

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, 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
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The COBE® Closed Venous Reservoir Bags With SMAR, T™ (Model Numbers VRB® 1200™ and VRB® 1800™) are intended to be used in adult surgical procedures requiring extracorporeal support for periods of 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 DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K980786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980786: Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980786

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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