510(k) Report

510(k) · Cleared

Cleared

Ksea Universal Laparomat Laparoscopic Suction and Irrigation Pump

K010569510(k) TraditionalCleared Apr 9, 200142-day reviewClass II21 CFR 876.1500

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

Karl Storz Endoscopy · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 9, 2001 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 9, 2001
Review
42 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 2 descendants cleared2022: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK010569 Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpKarl Storz Endoscopy · 2001
  2. Descendant · cites it directly · 1 of its ownK162992 Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc. · 2017
  3. Descendant · cites it directly · 1 of its ownK163320 LAP-Pump PP110W.O.M. World of Medicine GmbH · 2017
  4. Descendant · 2 generations on · 0 of its ownK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK173489 GYN-Pump PH304W.O.M. World of Medicine GmbH · 2018 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc. · 2017 · cites it directly1descendant
  • K163320LAP-Pump PP110W.O.M. World of Medicine GmbH · 2017 · cites it directly1descendant
  • K213334Monarch Platform, UrologyAuris Health, Inc. · 2022 · 2 generations on0descendants
  • K173489GYN-Pump PH304W.O.M. World of Medicine GmbH · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010569Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpKarl Storz Endoscopy2001—
+1K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.2017—
+1K163320LAP-Pump PP110W.O.M. World of Medicine GmbH2017—
+2K213334Monarch Platform, UrologyAuris Health, Inc.20221
+2K173489GYN-Pump PH304W.O.M. World of Medicine GmbH20181

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201810
202210
FIG. 1 — Lineage of K010569, 2001–2022Source: 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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.20171
K163320LAP-Pump PP110W.O.M. World of Medicine GmbH20171

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, K162992 (Karl Storz Endoscopy America, Inc., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

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https://510kreport.com/device/K010569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010569: Ksea Universal Laparomat Laparoscopic Suction and Irrigation Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010569

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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