510(k) · Cleared
ClearedHLS Cannula Non-Coated, with Bioline Coating and with Softline Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Feb 25, 2011 as substantially equivalent to K924642 (Medtronic Bio-Medicus, Inc., 1993) and 2 other predicates after a 175-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.
- Decided
- Feb 25, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K922933 (1992). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 7 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 6 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 5 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 4 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 3 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 2 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK102532 HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG · 2011
- Descendant · cites it directly · 0 of its ownK131666 Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with…Maquet Cardiopulmonary, AG · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −7 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −6 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −5 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −4 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −3 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −2 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −1 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| 0 (this device) | K102532 | HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating | Maquet Cardiopulmonary, AG | 2011 | — |
| +1 | K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline… | Maquet Cardiopulmonary, AG | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K924642 | Medtronic Bio-Medicus Femoral Cannula/IntroducerSummary page 1…Catheter, Cannulae and Tubing, Vascular, Cardiopulmonary Bypass Predicate Devices: Bio-Medicus Femoral Cannula, Medtronic USA, cleared under K924642, QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with SOFTLINE Coating, MAQUET Cardiopulmonary… | 1993 |
| * | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Summary page 1…cleared under K924642, QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with SOFTLINE Coating, MAQUET Cardiopulmonary AG, cleared under K0821 17, QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating, MAQUET Cardiopulmonary A… | 2009 |
| * | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Summary page 1…cleared under K0821 17, QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating, MAQUET Cardiopulmonary AG, cleared under K09051 1. MAQUET… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline Coating | 2013 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K131666 (Maquet Cardiopulmonary, AG, 2013) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K924642.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102532: HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102532
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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