510(k) Report

510(k) · Cleared

Cleared

Sterichek Total Chlorine Reagent Strips

K001194510(k) TraditionalCleared Jul 11, 200090-day reviewClass II21 CFR 876.5665

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

Environmental Test Systems, Inc. · MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Cleared on Jul 11, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 11, 2000
Review
90 days
Class
Class II
Product code
MSY
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared200020052010201520202025
  1. This deviceK001194 Sterichek Total Chlorine Reagent StripsEnvironmental Test Systems, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK080712 Serim Hisense Ultra 0.1, Part Number 5167Serim Research Corp. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080712Serim Hisense Ultra 0.1, Part Number 5167Serim Research Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001194Sterichek Total Chlorine Reagent StripsEnvironmental Test Systems, Inc.2000—
+1K080712Serim Hisense Ultra 0.1, Part Number 5167Serim Research Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K001194, 2000–2008Source: 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 MSY? 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 MSY device

  1. #1 K243898 Chlorine Sentinel IIscore 9.5 · 2 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K080712Serim Hisense Ultra 0.1, Part Number 5167Serim Research Corp.20080

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, K080712 (Serim Research Corp., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MSY devices

MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSY

1in 2025

2008: 12009: 12014: 12020: 12022: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSY

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

Recalls per year · MSY

No recall names MSY since 2007.

Adverse event reports per year · MSY

1in 2011

2007: 22008: 352011: 1
2007high 35 (2008) · low 0 (2009)2025

MAUDE reports naming product code MSY, 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—02
20081—035
20091—00
20100—00
20110—01
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20221—00
20230—00
20240—00
20251—00
20260—0—

More from Environmental Test Systems, Inc.

8 FDA decisions under this applicant name. See the company

  • K031267Sterichek Bicarb PH Reagent StripsEnvironmental Test Systems, Inc. · 2003
  • K003615Sterichek Sensitive-Feed Water and Rinse Water Reagent StripsEnvironmental Test Systems, Inc. · 20014 recalls
  • K994226Sterichek Total Chlorine Reagent StripsEnvironmental Test Systems, Inc. · 2000
  • K983997Sterichek Total Chlorine Test KitEnvironmental Test Systems, Inc. · 1999
  • K980164Sterichek Peracetic Acid Reagent StripsEnvironmental Test Systems, Inc. · 1998

Recent decisions in MSY

The MSY category page

  • K243898Chlorine Sentinel IINelson Environmental Technologies, Inc. · 2025
  • K222167E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc) · 2022
  • K193169Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc. · 2020
  • K132344E-Z Check Ozone Test StripsReprocessing Products Corporation (Rpc) · 2014
  • K090338Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineReprocessing Products Corp · 2009

https://510kreport.com/device/K001194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001194: Sterichek Total Chlorine Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001194

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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