510(k) Report

510(k) · Cleared

Cleared

Water for Assisted Reproductive Technologies (a.R.T.) Use

K011598510(k) TraditionalCleared Jun 13, 200120-day reviewClass II21 CFR 884.6170

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

Irvine Scientific Sales Co., Inc. · MTW System, Water, Reproduction, Assisted, And Purification

Cleared on Jun 13, 2001 after a 20-day review. The FDA summary names no predicate by number.

Decided
Jun 13, 2001
Review
20 days
Class
Class II
Product code
MTW
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K011598Source: FDA 510(k) database · 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 MTW? 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?

The FDA summary names no predicate by number.

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.

How does its category compare?

All MTW devices

MTW System, Water, Reproduction, Assisted, And Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MTW

FDA has decided no MTW device since 2007.

Median 510(k) review, days · MTW

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

Recalls per year · MTW

No recall names MTW since 2007.

Adverse event reports per year · MTW

No MAUDE report names MTW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Irvine Scientific Sales Co., Inc.

40 FDA decisions under this applicant name. See the company

  • K171224Arctic Sperm Cryopreservation MediumIrvine Scientific Sales Co., Inc. · 2017
  • K170681Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017
  • K170602Continuous Single Culture-NX Complete (CSCM-NXC)Irvine Scientific Sales Co., Inc. · 2017
  • K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
  • K121128Multipurpose Handling MediumIrvine Scientific Sales Co., Inc. · 2012

Recent decisions in MTW

The MTW category page

  • K993140Water for Tissue Culture, Models 1500Conception Technologies · 2000

https://510kreport.com/device/K011598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011598: Water for Assisted Reproductive Technologies (a.R.T.) Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011598

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026