510(k) Report

510(k) · Cleared

Recalled · 2009

Cobe Revolution

K011835510(k) AbbreviatedCleared Feb 12, 2002245-day reviewClass II21 CFR 870.4360Recalls 1

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

Cobe Cardiovascular, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cleared on Feb 12, 2002 as substantially equivalent to K852698 (Bio Medicus, Inc., 1985) after a 245-day review. Its family tree reaches back 1 generation to 1985. 12 later devices descend from it. It has been recalled once.

Decided
Feb 12, 2002
Review
245 days
Class
Class II
Product code
KFM
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K852698 (1985). 12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2019: 1 descendant cleared2021: 2 descendants cleared2020: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK852698 · Bio Medicus Bio Pump Model BP-80 · Bio Medicus, Inc. · 19851990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K852698 · Bio Medicus Bio Pump Model BP-80 · Bio Medicus, Inc. · 19850+5
  1. Root · 1 generation backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
  2. This deviceK011835 Cobe RevolutionCobe Cardiovascular, Inc. · 2002
  3. Descendant · cites it directly · 9 of its ownK030462 Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK192850 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
  5. Descendant · 3 generations on · 3 of its ownK202169 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
  6. Descendant · cites it directly · 3 of its ownK030154 Ideal: System with Integrated Venous Air Removal, Centrifugal Blood…Dideco S.P.A. · 2003
  7. Descendant · 4 generations on · 2 of its ownK201320 Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 2021 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 32005: 12008: 12019: 12020: 22021: 22023: 12025: 1
2003high 3 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 2003 · cites it directly9descendants
  • K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L · 2020 · 2 generations on4descendants
  • K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L · 2020 · 3 generations on3descendants
  • K030154Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…Dideco S.P.A. · 2003 · cites it directly3descendants
  • K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K852698Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc.1985—
0 (this device)K011835Cobe RevolutionCobe Cardiovascular, Inc.2002—
+1K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc.20031
+2K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal…Qura S.R.L2020—
+3K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal…Qura S.R.L2020—
+1K030154Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Dideco S.P.A.2003—
+4K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200510
200810
201910
202020
202120
202310
202510
FIG. 1 — Lineage of K011835, 1985–2025Source: 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 KFM? 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 KFM device

  1. #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 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
*K852698Bio Medicus Bio Pump Model BP-80
Summary page 1
…l Blood Pump CLASSIFICATION NAME: Non-roller type cardiopulmonary bypass blood pump (21 CFR 870.4360) PREDICATE DEVICE: Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698) DEVICE DESCRIPTION: The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vane…
Bio Medicus, Inc.1985—

Also cleared against K852698: 3 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc.20039
K030154Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…Dideco S.P.A.20033
K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation20210
K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 25, 2009Not classifiedZ-0192-2010Packaging change controlA weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K030462 (Cobe Cardiovascular, Inc., 2003) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K852698.

How does its category compare?

All KFM devices

KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KFM

2in 2025

2008: 42009: 52010: 32011: 72013: 22017: 12019: 32020: 32021: 32023: 32025: 2
2007high 7 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KFM

30in 2023

2008: 194 days median2009: 184 days median2010: 109 days median2011: 16 days median2019: 147 days median2020: 30 days median2021: 534 days median2023: 30 days median
2007high 534 (2021) · low 16 (2011)2026

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

Recalls per year · KFM

2in 2024

2008: 22009: 42010: 22011: 12012: 52018: 12019: 3, 1 Class I2024: 2
2007high 5 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KFM

249in 2025

2007: 602008: 622009: 852010: 812011: 572012: 822013: 1042014: 3472015: 2992016: 1562017: 1212018: 1762019: 3112020: 4372021: 4462022: 2942023: 3462024: 2962025: 249
2007high 446 (2021) · low 57 (2011)2025

MAUDE reports naming product code KFM, 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—060
20084194262
20095184485
20103109281
2011716157
20120—582
20132—0104
20140—0347
20150—0299
20160—0156
20171—0121
20180—1176
201931473 (1)311
20203300437
202135340446
20220—0294
20233300346
20240—2296
20252—0249
20260—0—

What is it indicated for?

The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stéckert

Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours.

The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e.,

longer than six hours) as a bridge to transplant, for pending recovery of the natural heart, or

extracorporeal membrane oxygenation (ECMO) procedures.

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

Also cleared against K852698

3 other devices cite the same predicate.

  • K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
  • K983272Ibc Flopump, Model 6000International Biophysics Corp. · 1999
  • K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998

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 KFM

The KFM category page

  • K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L. · 2025
  • K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L. · 2025
  • K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion…Qura S.R.L · 2023
  • K232132LifeSPARC SystemCardiacassist, Inc. · 2023
  • K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood…Qura S.R.L · 2023

https://510kreport.com/device/K011835 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011835: Cobe Revolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011835

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026