510(k) Report

510(k) · Cleared

Cleared

Piggyback Irrigating System

K040094510(k) AbbreviatedCleared Apr 15, 200490-day reviewClass II21 CFR 876.5130

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

Kosin Technologies, LLC · LJH System, Irrigation, Urological

Cleared on Apr 15, 2004 as substantially equivalent to K905102 (C.R. Bard, Inc., 1991) after a 90-day review. Its family tree reaches back 1 generation to 1991.

Decided
Apr 15, 2004
Review
90 days
Class
Class II
Product code
LJH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K905102 (1991). No later device cites it as a predicate yet.

K905102 · Bard (R) Syringe Assist Irrigation · C.R. Bard, Inc. · 19911990199520002005
K905102 · Bard (R) Syringe Assist Irrigation · C.R. Bard, Inc. · 19910
  1. Root · 1 generation backK905102 Bard (R) Syringe Assist IrrigationC.R. Bard, Inc. · 1991
  2. This deviceK040094 Piggyback Irrigating SystemKosin Technologies, LLC · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905102Bard (R) Syringe Assist IrrigationC.R. Bard, Inc.1991—
0 (this device)K040094Piggyback Irrigating SystemKosin Technologies, LLC2004—
FIG. 1 — Lineage of K040094, 1991–2004Source: 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 LJH? 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 LJH device

  1. #1 K254111 Irrigation/Urology Setsscore 12.0 · 1 generation · no Class I recall
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What was it cleared against? (1)

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
*K905102Bard (R) Syringe Assist Irrigation
Summary page 1
…Classification Name: Endoscope And/Or Accessories Predicate Device: C.R. Bard Syringe Assist Irrigation 5 10(k) #K905 102 Description of the Device: The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endosc…
C.R. Bard, Inc.1991—

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?

  • Its one ancestor has no recall.

How does its category compare?

All LJH devices

LJH System, Irrigation, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJH

1in 2017

2007: 32017: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJH

77in 2007

2007: 77 days median
2007high 77 (2007)2026

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

Recalls per year · LJH

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LJH

25in 2025

2008: 12010: 302011: 272012: 222013: 442014: 972015: 6422016: 322017: 192018: 182019: 162020: 232021: 152022: 212023: 342024: 132025: 25
2007high 642 (2015) · low 0 (2007)2025

MAUDE reports naming product code LJH, 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
200737700
20080—01
20090—00
20100—030
20110—027
20120—022
20130—044
20140—097
20150—0642
20160—032
20171—019
20180—018
20190—016
20200—023
20210—015
20220—121
20230—034
20240—013
20250—025
20262—0—

What is it indicated for?

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

Indications for use as stated in the FDA summary.

Recent decisions in LJH

The LJH category page

  • K261670Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR…Poly Medicure Limited · 2026
  • K254111Irrigation/Urology SetsB.Braun Medical, Inc. · 2026
  • K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc. · 2017
  • K070873Amsure Bladder Irrigation SetAmsino Intl., Inc. · 2007
  • K071832Modifcation to: Spyglass Irrigation SystemMedical Scientific, Inc. · 2007

https://510kreport.com/device/K040094 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040094: Piggyback Irrigating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040094

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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