510(k) Report

510(k) · Decided

Recalled · Class II · 2016

Signature (TM) Custom Tubing Pack

K924529510(k) TraditionalDecided Jun 23, 1993288-day reviewClass II21 CFR 870.4210Recalls 2

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

Avecor Cardiovascular, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jun 23, 1993 after a 288-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled 2 times.

Decided
Jun 23, 1993
Review
288 days
Class
Class II
Product code
DWF
Recalls
2
Predicates
0

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

Descendants, by year cleared 2012: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2026: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK924529 Signature (TM) Custom Tubing PackAvecor Cardiovascular, Inc. · 1993
  2. Descendant · cites it directly · 7 of its ownK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
  5. Descendant · 3 generations on · 3 of its ownK171308 Tubing PackMedtronic, Inc. · 2017 · Recalled
  6. Descendant · 4 generations on · 2 of its ownK171979 Tubing PackMedtronic, Inc. · 2017 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 32015: 12017: 22022: 12026: 1
2012high 3 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly7descendants
  • K122811Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · 2 generations on5descendants
  • K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015 · 2 generations on4descendants
  • K171308Tubing PackMedtronic, Inc. · 2017 · 3 generations on3descendants
  • K171979Tubing PackMedtronic, Inc. · 2017 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924529Signature (TM) Custom Tubing PackAvecor Cardiovascular, Inc.1993—
+1K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc.20121
+2K122811Connector Components with Balance BiosurfaceMedtronic, Inc.20121
+2K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc.2015—
+3K171308Tubing PackMedtronic, Inc.20171
+4K171979Tubing PackMedtronic, Inc.201725

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201510
201720
202210
202610
FIG. 1 — Lineage of K924529, 1993–2026Source: 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), 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. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc.20127

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 16, 2016Class IIZ-0826-2017Process controlMedtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion…
Feb 4, 2016Class IIIZ-1023-2016Component design/selectionMedtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K113845 (Medtronic, Inc., 2012) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

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

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

More from Avecor Cardiovascular, Inc.

9 FDA decisions under this applicant name. See the company

  • K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 19982 recalls
  • K964017Affinity Blood Pump SystemAvecor Cardiovascular, Inc. · 1997
  • K971105Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
  • K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 19951 recall
  • K940126Avecor Pre-Bypass FilterAvecor Cardiovascular, Inc. · 1994

Recent decisions in DWF

The DWF category page

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  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K924529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924529: Signature (TM) Custom Tubing Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924529

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026