510(k) Report

510(k) · Cleared

Cleared

Medtronic Octopus TE Stabilizer & Accessories

K041338510(k) TraditionalCleared Jul 19, 200460-day reviewClass I21 CFR 870.4500

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

Medtronic Vascular · MWS Stabilizer, Heart

Cleared on Jul 19, 2004 as substantially equivalent to K964445 (Dlp, Inc., 1997) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1997. 1 of the 160 devices in its family, counting itself, has a Class I recall. 157 later devices descend from it.

Decided
Jul 19, 2004
Review
60 days
Class
Class I
Product code
MWS
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K964445 (1997). 157 later devices descend from it, 2 citing it directly. 1 of the 160 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2014: 5 descendants cleared2017: 7 descendants cleared2012: 1 descendant cleared2019: 5 descendants cleared2018: 9 descendants cleared2016: 7 descendants cleared2020: 12 descendants cleared2021: 12 descendants cleared2022: 13 descendants cleared2011: 1 descendant cleared2025: 26 descendants cleared2024: 18 descendants cleared2015: 2 descendants cleared2026: 18 descendants cleared2023: 17 descendants cleared, 1 with a Class I recall1Reference device: K973485 · Clearview Blower/Mister · Dlp, Inc. · 1997 · recalledK964445 · Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006) · Dlp, Inc. · 1997K992833 · Vacuum Assist Stabilizer · Cardio Thoracic Systems · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 21 descendants4 generations forward: 22 descendants, 1 with a Class I recall15 generations forward: 18 descendants6 generations forward: 14 descendants7 generations forward: 21 descendants8 generations forward: 18 descendants9 generations forward: 16 descendants10 generations forward: 15 descendants11 generations forward: 6 descendants12 generations forward: 1 descendant K992833 · Vacuum Assist Stabilizer · Cardio Thoracic Systems · 1999K964445 · Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006) · Dlp, Inc. · 19970+5+10
  1. Root · 2 generations backK964445 Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
  2. 1 generation backK992833 Vacuum Assist StabilizerCardio Thoracic Systems · 1999
  3. This deviceK041338 Medtronic Octopus TE Stabilizer & AccessoriesMedtronic Vascular · 2004
  4. Descendant · cites it directly · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  6. Descendant · 3 generations on · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  7. Descendant · 3 generations on · 124 of its ownK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  8. Descendant · 4 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled

Showing 5 of 157 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 12011: 12012: 12014: 52015: 22016: 72017: 72018: 92019: 52020: 122021: 122022: 132023: 172024: 182025: 262026: 18
2006high 26 (2025) · low 0 (2010)2026

Class I recalls in this family

  • K223095 Senhance Surgical System4 generations on · 2023

Most influential descendants

Showing 5 of 157 · See all
  • K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · cites it directly155descendants
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · 2 generations on153descendants
  • K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · 3 generations on148descendants
  • K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · 3 generations on124descendants
  • K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc.1997—
−1K992833Vacuum Assist StabilizerCardio Thoracic Systems1999—
0 (this device)K041338Medtronic Octopus TE Stabilizer & AccessoriesMedtronic Vascular2004—
+1K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061
+2K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
+3K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
+3K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
+4K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200910
201110
201210
201450
201520
201670
201770
201890
201950
2020120
2021120
2022130
2023171
2024180
2025260
2026180
FIG. 1 — Lineage of K041338, 1997–2026Source: 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), 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)
Summary page 1
…equivalent in patient population, intended use, function and basic system components to the Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833). The Medtronic Octopus TE Stab…
Dlp, Inc.1997—
*K992833Vacuum Assist Stabilizer
Summary page 1
…and basic system components to the Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833). The Medtronic Octopus TE Stabilizer has an optional irrigator (lavage) that is designe…
Cardio Thoracic Systems1999—
†K973485Clearview Blower/MisterDlp, Inc.19971

Also cleared against K964445: 3 other devices →

What descends from it? (157)

See all 157

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.2006155
K070036Reprocessed Medtronic Cardiac Stabilization and Positioning DevicesAscent Healthcare Solutions20070

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K060391 (Intuitive Surgical, Inc., 2006) has gone furthest, with 155 descendants of its own.
  • 3 other devices also cite its predicate K964445.

How does its category compare?

All MWS devices

MWS Stabilizer, Heart: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWS

FDA has decided no MWS device since 2007.

Median 510(k) review, days · MWS

Too few MWS 510(k)s in any year since 2007 to give a median.

Recalls per year · MWS

3in 2024

2011: 22014: 12023: 22024: 32026 (partial year): 3
2007high 3 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWS

63in 2025

2007: 272008: 82009: 72010: 162011: 902012: 202013: 222014: 342015: 662016: 522017: 452018: 542019: 592020: 432021: 742022: 982023: 672024: 562025: 63
2007high 98 (2022) · low 7 (2009)2025

MAUDE reports naming product code MWS, 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—027
20080—08
20090—07
20100—016
20110—290
20120—020
20130—022
20140—134
20150—066
20160—052
20170—045
20180—054
20190—059
20200—043
20210—074
20220—098
20230—267
20240—356
20250—063
20260—3—

What is it indicated for?

The Stabilizer is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

Indications for use as stated in the FDA summary.

Also cleared against K964445

3 other devices cite the same predicate.

  • K070036Reprocessed Medtronic Cardiac Stabilization and Positioning DevicesAscent Healthcare Solutions · 2007
  • K063844Reprocessed Heart Stabilizers and PositionersSterilmed, Inc. · 2007
  • K992833Vacuum Assist StabilizerCardio Thoracic Systems · 1999

More from Medtronic Vascular

1,057 FDA decisions under this applicant name. See the company

  • P160043/S096Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular · 2026
  • P160043/S095Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026
  • P160043/S093Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S092Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026

Recent decisions in MWS

The MWS category page

  • K992476Pilling Weck Surgical Heart Stabilizer Removable PadsPilling Weck Surgical · 2000
  • K992833Vacuum Assist StabilizerCardio Thoracic Systems · 1999
  • K982419Heart-Lift Balloon PositionerCardiothoracic Systems, Inc. · 1999

https://510kreport.com/device/K041338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041338: Medtronic Octopus TE Stabilizer & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041338

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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