510(k) Report

510(k) · Cleared

Cleared

Gentle Header

K902845510(k) TraditionalCleared Dec 3, 1990158-day reviewClass II21 CFR 870.4390

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

Enhanced Perfusion Systems, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass

Cleared on Dec 3, 1990 after a 158-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Dec 3, 1990
Review
158 days
Class
Class II
Product code
DWE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK902845 Gentle HeaderEnhanced Perfusion Systems, Inc. · 1990
  2. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  3. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  5. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  6. Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12025: 12026: 2
2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902845Gentle HeaderEnhanced Perfusion Systems, Inc.1990—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
202510
202620
FIG. 1 — Lineage of K902845, 1990–2026Source: 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 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
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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? (6)

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

NumberDeviceApplicantDecidedDescendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115

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?

  • Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 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—

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/K902845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902845: Gentle Header.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902845

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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