510(k) Report

510(k) · Cleared

Recalled · 2005

Cardio Metric Custom Perfusion Tubing

K841959510(k) TraditionalCleared Oct 19, 1984158-day reviewClass II21 CFR 870.4390Recalls 1

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

Sterile Design, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass

Cleared on Oct 19, 1984 after a 158-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Oct 19, 1984
Review
158 days
Class
Class II
Product code
DWE
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared19801990200020102020
  1. This deviceK841959 Cardio Metric Custom Perfusion TubingSterile Design, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK092644 Terumo Pressure IsolatorTerumo Cardiovascular Systems Corp. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K092644Terumo Pressure IsolatorTerumo Cardiovascular Systems Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K841959Cardio Metric Custom Perfusion TubingSterile Design, Inc.1984—
+1K092644Terumo Pressure IsolatorTerumo Cardiovascular Systems Corp.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K841959, 1984–2009Source: 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 DWE? 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. #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K092644Terumo Pressure IsolatorTerumo Cardiovascular Systems Corp.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 16, 2005Not classifiedZ-1222-06OtherTyvek pouches containing device labeled as sterile have defective seals.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092644 (Terumo Cardiovascular Systems Corp., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWE devices

DWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWE

1in 2024

2008: 12009: 12014: 12015: 12024: 1
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

2007: 22009: 12010: 22011: 22014: 12017: 2
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

2007: 102008: 122009: 172010: 202011: 92012: 72013: 212014: 1292015: 1332016: 1512017: 1312018: 1342019: 822020: 452021: 412022: 1232023: 2862024: 2212025: 80
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—210
20081—012
20091—117
20100—220
20110—29
20120—07
20130—021
20141—1129
20151—0133
20160—0151
20170—2131
20180—0134
20190—082
20200—045
20210—041
20220—0123
20230—0286
20241—0221
20250—080
20260—0—

More from Sterile Design, Inc.

10 FDA decisions under this applicant name. See the company

  • K934688Sterile DesignSterile Design, Inc. · 1994
  • K841960Cardio Metrics Invasive Pressure MonitSterile Design, Inc. · 1985
  • K842356Custom Sterile Procedure KitsSterile Design, Inc. · 1985
  • K842351Sterile Design-Custom Sterile IV KitSterile Design, Inc. · 1984
  • K841958Cardio Metrics Cardiotomy ReservoirSterile Design, Inc. · 1984

Recent decisions in DWE

The DWE category page

  • K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc. · 2024
  • K150542Terumo Pump TubingTerumo Cardiovascular Systems Corporation · 2015
  • K142607AngioVac CircuitAngiodynamics · 20141 recall
  • K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 20091 recall
  • K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008221 recalls

https://510kreport.com/device/K841959 · printed Nov 4, 2026

Cite this page

510(k) Report. “K841959: Cardio Metric Custom Perfusion Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K841959

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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