510(k) Report

510(k) · Cleared

Cleared

Estech Clearview MV Atrial Depressor

K053021510(k) TraditionalCleared Jan 26, 200692-day reviewClass II21 CFR 870.4420

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

Estech, Inc. · DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Cleared on Jan 26, 2006 as substantially equivalent to K982891 (California Medical Laboratories, Inc., 1998) and 1 other predicate after a 92-day review. Its family tree reaches back 1 generation to 1997.

Decided
Jan 26, 2006
Review
92 days
Class
Class II
Product code
DTS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K963756 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK963756 · Ibc Cardiac Suction Ward · International Biophysics Corp. · 1997 · recalled1996199820002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor K963756 · Ibc Cardiac Suction Ward · International Biophysics Corp. · 1997 · recalled0
  1. Root · 1 generation backK963756 Ibc Cardiac Suction WardInternational Biophysics Corp. · 1997 · Recalled
  2. This deviceK053021 Estech Clearview MV Atrial DepressorEstech, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963756Ibc Cardiac Suction WardInternational Biophysics Corp.19972
0 (this device)K053021Estech Clearview MV Atrial DepressorEstech, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K053021, 1997–2006Source: 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.

Planning a device in DTS? 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
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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
*K982891California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands
Summary page 1
…Device Information: Predicate Devices: California Medical Laboratories Rigid Tip Suction Wands (K982891) IBC Cardiac Suction Wand (K963756) Predicate Device Manufacturers: C…
California Medical Laboratories, Inc.199810
*K963756Ibc Cardiac Suction Ward
Summary page 1
…ical Laboratories Rigid Tip Suction Wands (K982891) IBC Cardiac Suction Wand (K963756) Predicate Device Manufacturers: California Medical Laboratories Inte…
International Biophysics Corp.19972

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 2 of the 2 ancestors have a recall of any class.

How does its category compare?

All DTS devices

DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTS

FDA has decided no DTS device since 2007.

Median 510(k) review, days · DTS

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

Recalls per year · DTS

2in 2012

2008: 42011: 32012: 2
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DTS

17in 2025

2007: 12008: 12010: 12011: 42012: 82013: 32014: 1072016: 12017: 22018: 32019: 32020: 22021: 112022: 112023: 122024: 202025: 17
2007high 107 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTS, 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—01
20080—41
20090—00
20100—01
20110—34
20120—28
20130—03
20140—0107
20150—00
20160—01
20170—02
20180—03
20190—03
20200—02
20210—011
20220—011
20230—012
20240—020
20250—017
20260—0—

What is it indicated for?

The ESTECH Clearview TM MV Atrial Depressor is intended to remove

excess fluids from the surgical field for filtering and return to the patient

during cardiopulmonary bypass of up to 6 hours. It can also be used to

retract tissue to increase visibility.

Indications for use as stated in the FDA summary.

More from Estech, Inc.

7 FDA decisions under this applicant name. See the company

  • K133017Estech Cobra (R) Genesis Bipolar ClampEstech, Inc. · 2013
  • K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 20051 recall
  • K051749Cobra Surgical SystemEstech, Inc. · 2005
  • K041599Cobra Adhere Surgical SystemEstech, Inc. · 2004
  • K032632Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 2003

Recent decisions in DTS

The DTS category page

  • K982891California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsCalifornia Medical Laboratories, Inc. · 199810 recalls
  • K963756Ibc Cardiac Suction WardInternational Biophysics Corp. · 19972 recalls
  • K905008Flexible Intracardiac Suction DeviceGish Biomedical, Inc. · 1991
  • K900339Hand-Held Intracardiac Suckers W/Ergonomic HandlesShiley, Inc. · 1990
  • K891906Robicsek Intracardiac Suction WandGish Biomedical, Inc. · 1989

https://510kreport.com/device/K053021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053021: Estech Clearview MV Atrial Depressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053021

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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