510(k) · Cleared

Cleared

Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)

K964445510(k) TraditionalCleared Jan 30, 199785-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

Dlp, Inc. · DWS Instruments, Surgical, Cardiovascular

Cleared on Jan 30, 1997 after an 85-day review. The FDA summary names its predicate without a number. 1 of the 162 devices in its family, counting itself, has a Class I recall. 161 later devices descend from it.

Decided: Jan 30, 1997
Review: 85 days
Class: Class I
Product code: DWS
Recalls: None
Predicates: 0

161 later devices descend from it, 4 citing it directly. 1 of the 162 devices in this family, counting this one, has a Class I recall.

This deviceK964445 Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
Descendant · cites it directly · 159 of its ownK992833 Vacuum Assist StabilizerCardio Thoracic Systems · 1999
Descendant · cites it directly · 157 of its ownK041338 Medtronic Octopus TE Stabilizer & AccessoriesMedtronic Vascular · 2004
Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
Descendant · 3 generations on · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
Descendant · 4 generations on · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled

Showing 5 of 161 descendants. See all descendants

Descendants cleared per year

1999high 26 (2025) · low 0 (2000)2026

Class I recalls in this family

K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 161 · See all

K992833Vacuum Assist StabilizerCardio Thoracic Systems · 1999 · cites it directly159descendants
K041338Medtronic Octopus TE Stabilizer & AccessoriesMedtronic Vascular · 2004 · cites it directly157descendants
K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · 2 generations on155descendants
K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · 3 generations on153descendants
K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · 4 generations on148descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964445	Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)	Dlp, Inc.	1997	—
+1	K992833	Vacuum Assist Stabilizer	Cardio Thoracic Systems	1999	—
+1	K041338	Medtronic Octopus TE Stabilizer & Accessories	Medtronic Vascular	2004	—
+2	K060391	Intuitive Surgical Endowrist Stabilizer, Model 420182	Intuitive Surgical, Inc.	2006	1
+3	K090993	Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…	Intuitive Surgical, Inc.	2009	3
+4	K123463	Intuitive Surgical DA Vinci SI Surgical System Smartpedals	Intuitive Surgical, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0
2006	1	0
2007	3	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2014	5	0
2015	2	0
2016	7	0
2017	7	0
2018	9	0
2019	5	0
2020	12	0
2021	12	0
2022	13	0
2023	17	1
2024	18	0
2025	26	0
2026	18	0

FIG. 1 — Lineage of K964445, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer Named without a submission number			—
*	—	DLP Cardiac Suction Tube Named without a submission number			—

What descends from it? (161)

See all 161

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

Number	Device	Applicant	Decided	Descendants
K992833	Vacuum Assist Stabilizer	Cardio Thoracic Systems	1999	159
K041338	Medtronic Octopus TE Stabilizer & Accessories	Medtronic Vascular	2004	157
K070036	Reprocessed Medtronic Cardiac Stabilization and Positioning Devices	Ascent Healthcare Solutions	2007	0
K063844	Reprocessed Heart Stabilizers and Positioners	Sterilmed, Inc.	2007	0

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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K992833 (Cardio Thoracic Systems, 1999) has gone furthest, with 159 descendants of its own.

How does its category compare?

All DWS devices

DWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWS

FDA has decided no DWS device since 2007.

Median 510(k) review, days · DWS

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

Recalls per year · DWS

1in 2022

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DWS

12in 2025

2007high 60 (2018) · low 12 (2025)2025

MAUDE reports naming product code DWS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	20
2008	—	0	15
2009	—	0	44
2010	—	1	27
2011	—	1	55
2012	—	0	33
2013	—	0	34
2014	—	0	43
2015	—	0	26
2016	—	1	33
2017	—	0	40
2018	—	0	60
2019	—	0	28
2020	—	0	28
2021	—	0	32
2022	—	1	35
2023	—	0	18
2024	—	0	48
2025	—	0	12
2026	—	0	—

What is it indicated for?

Both are intended for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964445 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964445

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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