510(k) Report

510(k) · Cleared

Cleared

Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation

K003402510(k) TraditionalCleared May 1, 2001181-day reviewClass II21 CFR 880.6740

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

Welcon, Inc. · JOL Catheter And Tip, Suction

Cleared on May 1, 2001 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided
May 1, 2001
Review
181 days
Class
Class II
Product code
JOL
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 1 descendant cleared, 1 with a Class I recall12017: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003402 Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9%…Welcon, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
  3. Descendant · 2 generations on · 2 of its ownK161311 USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9%…Strukmyer Medical, LLC · 2016
  4. Descendant · 2 generations on · 1 of its ownK173276 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK172486 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline…Anexa Biomedical, Inc. · 2017
  6. Descendant · 3 generations on · 0 of its ownK243001 Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12016: 22017: 22018: 22025: 1
2008high 2 (2016) · low 0 (2009)2026

Class I recalls in this family

  • K083042 Wound Flush, Sterile Water & Normal Salinecites it directly · 2008

Most influential descendants

Showing 5 of 8 · See all
  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · cites it directly7descendants
  • K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC · 2016 · 2 generations on2descendants
  • K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · 2 generations on1descendant
  • K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc. · 2017 · 2 generations on1descendant
  • K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003402Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline…Welcon, Inc.2001—
+1K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc.2008Class I
+2K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium…Strukmyer Medical, LLC2016—
+2K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.20181
+2K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%…Anexa Biomedical, Inc.2017—
+3K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200811
201620
201720
201820
202510
FIG. 1 — Lineage of K003402, 2001–2025Source: 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.

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?

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

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K083042Wound Flush, Sterile Water & Normal Saline Class INurse Assist, Inc.20087
K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific20170

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.

  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K083042 (Nurse Assist, Inc., 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JOL devices

JOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOL

FDA has decided no JOL device since 2007.

Median 510(k) review, days · JOL

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

Recalls per year · JOL

1in 2023

2012: 12019: 32023: 1, 1 Class I2026 (partial year): 1
2007high 3 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JOL

277in 2025

2007: 172008: 142009: 172010: 252011: 172012: 252013: 342014: 422015: 272016: 612017: 1812018: 1612019: 4422020: 1872021: 2832022: 2212023: 1972024: 2772025: 277
2007high 442 (2019) · low 14 (2008)2025

MAUDE reports naming product code JOL, 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—017
20080—014
20090—017
20100—025
20110—017
20120—125
20130—034
20140—042
20150—027
20160—061
20170—0181
20180—0161
20190—3442
20200—0187
20210—0283
20220—0221
20230—1 (1)197
20240—0277
20250—0277
20260—1—

More from Welcon, Inc.

8 FDA decisions under this applicant name. See the company

  • K973734Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationWelcon, Inc. · 1998
  • K971764Welcon Hue-VU Urinary Drainage BagWelcon, Inc. · 1997
  • K912869Women and Infant's Delivery PackWelcon, Inc. · 1991
  • K904158Accorde (R) Irrigating Syringe/Procedure TrayWelcon, Inc. · 1990
  • K894397Welcon Light HandleWelcon, Inc. · 1989

Recent decisions in JOL

The JOL category page

  • K051370Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014Baxter Healthcare Corp · 2005
  • K000265Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 2001
  • K000266Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device IrrigationPrimary Care Solutions, Inc. · 2001
  • K994321Sterile Water and 0.9% Sodium Chloride for Irrigation, UspAutomatic Liquid Packaging, Inc. · 2000
  • K974758Hydrox Sterile Water 4 OZ. Cup 120 ML., Hydrox Sterile Water 100 ML BottleHydrox Laboratories · 1998

https://510kreport.com/device/K003402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003402: Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003402

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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