510(k) Report

510(k) · Cleared

Cleared

Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer

K955152510(k) TraditionalCleared Feb 22, 1996101-day reviewClass II21 CFR 870.4340

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

Stoeckert Instrumente · DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Cleared on Feb 22, 1996 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 22, 1996
Review
101 days
Class
Class II
Product code
DTW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955152 Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont.…Stoeckert Instrumente · 1996
  2. Descendant · cites it directly · 1 of its ownK041558 Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004
  3. Descendant · 2 generations on · 0 of its ownK103469 Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K041558Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004 · cites it directly1descendant
  • K103469Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955152Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., TimerStoeckert Instrumente1996—
+1K041558Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH2004—
+2K103469Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
FIG. 1 — Lineage of K955152, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DTW? 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?

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

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K041558Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH20041

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, K041558 (Stockert Instrumente GmbH, 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DTW devices

DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTW

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTW

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

Recalls per year · DTW

5in 2007

2007: 5
2007high 5 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DTW

4in 2024

2009: 12010: 42011: 42012: 202013: 62014: 22015: 112016: 222017: 472018: 62019: 152020: 22021: 22024: 4
2007high 47 (2017) · low 0 (2007)2025

MAUDE reports naming product code DTW, 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—50
20080—00
20090—01
20100—04
20110—04
20120—020
20130—06
20140—02
20151—011
20160—022
20170—047
20180—06
20190—015
20200—02
20210—02
20220—00
20230—00
20240—04
20250—00
20260—0—

More from Stoeckert Instrumente

13 FDA decisions under this applicant name. See the company

  • K002273Stockert A272 Series Pediatric Aortic CannulaeStoeckert Instrumente · 2001
  • K001961Stockert A242 and A252 Series Arterial Femoral CannulaeStoeckert Instrumente · 2001
  • K002118Stockert Compact System Version 2.0Stoeckert Instrumente · 2000
  • K992635Interface Module IdddStoeckert Instrumente · 1999
  • K990512Stockert Power Supply Unit for S3 ComponentsStoeckert Instrumente · 1999

Recent decisions in DTW

The DTW category page

  • K150530Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015
  • K041558Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004
  • K992857Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070Rocky Mountain Research, Inc. · 1999
  • K910599Cardiopulmonary Bypass Level Sensing MonitorJtl Medical Corp. · 1993
  • K924354Stockert Caps Low Level Detect II/Bubble MonitorSorin Biomedica, Fiat, USA, Inc. · 1993

https://510kreport.com/device/K955152 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955152: Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955152

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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