510(k) · Cleared
Recalled · Class II · 2019HLM Tubing Set with Bioline Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Sep 11, 2008 as substantially equivalent to K053025 (Maquet Cardiopulmonary, AG, 2005) and 1 other predicate after a 192-day review. Its family tree reaches back 5 generations to 1993. 3 of the 23 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 221 times.
- Decided
- Sep 11, 2008
- Review
- 192 days
- Class
- Class II
- Product code
- DWE
- Recalls
- 221
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932252 (1993). 14 ancestors in all, the oldest K771692 (1977). 8 later devices descend from it, 4 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 4 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 3 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 2 generations backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- 1 generation backK071774 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG · 2008
- This deviceK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008
- Descendant · cites it directly · 3 of its ownK090533 HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009
- Descendant · cites it directly · 2 of its ownK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK223161 OXY-1 SystemAbiomed, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222297 CentriMag Pre-connected PackAbbott · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
2009high 2 (2009) · low 0 (2010)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · cites it directly3descendants
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · cites it directly2descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · cites it directly2descendants
- K223161OXY-1 SystemAbiomed, Inc. · 2023 · 2 generations on0descendants
- K222297CentriMag Pre-connected PackAbbott · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −4 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −3 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −2 | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| −1 | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2008 | — |
| 0 (this device) | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | — |
| +1 | K090533 | HLM Tubing Set with Softline Coating | Maquet Cardiopulmonary, AG | 2009 | — |
| +1 | K200109 | OXY-1 System | Abiomed, Inc. | 2020 | Class I |
| +1 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +2 | K223161 | OXY-1 System | Abiomed, Inc. | 2023 | — |
| +2 | K222297 | CentriMag Pre-connected Pack | Abbott | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2020 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 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.
3 devices in this family have a Class I recall. 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 DWE device
- #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053025 | Jostra HLM Tubing SetSummary page 1…k, Manifold, or Fitting; Cardiopulmonary Bypass Pump Tubing. PREDICATE DEVICES OR LEGALLY MARKETED DEVICES Jostra HLM Tubing Sets (K053025) Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774) DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT… | 2005 |
| * | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Summary page 1…ry Bypass Pump Tubing. PREDICATE DEVICES OR LEGALLY MARKETED DEVICES Jostra HLM Tubing Sets (K053025) Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774) DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT The HLM Tubing Sets with Bioline Coating are for single use only. They ma… | 2008 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2019 | Class II | Z-1534-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1597-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1645-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1513-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1543-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1541-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1590-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1648-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1605-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1622-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1606-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1641-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1506-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1666-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1586-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1500-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1508-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1658-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1585-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1644-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1565-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1612-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1578-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1593-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1525-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1615-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1646-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1552-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1518-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1549-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1634-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1621-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1511-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1608-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1635-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1509-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1503-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1656-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1620-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1517-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1671-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1529-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1663-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1662-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1618-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1537-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1676-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1594-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1561-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
| Apr 18, 2019 | Class II | Z-1661-2019 | Device Design | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the… |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K090533 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K053025.
How does its category compare?
All DWE devicesDWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DWE
1in 2024
2007high 1 (2008) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DWE
Too few DWE 510(k)s in any year since 2007 to give a median.
Recalls per year · DWE
2in 2017
2007high 2 (2007) · low 0 (2008)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWE
80in 2025
2007high 286 (2023) · low 7 (2012)2025
MAUDE reports naming product code DWE, 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 | 0 | — | 2 | 10 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 1 | 17 |
| 2010 | 0 | — | 2 | 20 |
| 2011 | 0 | — | 2 | 9 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 1 | — | 1 | 129 |
| 2015 | 1 | — | 0 | 133 |
| 2016 | 0 | — | 0 | 151 |
| 2017 | 0 | — | 2 | 131 |
| 2018 | 0 | — | 0 | 134 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 286 |
| 2024 | 1 | — | 0 | 221 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080592: HLM Tubing Set with Bioline Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080592
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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