510(k) Report

510(k) · Cleared

Cleared

Urine Reagent Strip-3 Parameters

K940469510(k) TraditionalCleared Sep 9, 1994219-day reviewClass II21 CFR 862.1340

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

Teco Diagnostics · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Cleared on Sep 9, 1994 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Sep 9, 1994
Review
219 days
Class
Class II
Product code
JIL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 1 descendant cleared1990200020102020
  1. This deviceK940469 Urine Reagent Strip-3 ParametersTeco Diagnostics · 1994
  2. Descendant · cites it directly · 0 of its ownK131600 Urs-2GP (Glucose Protein) Urine StripsTeco Diagnostics · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K131600Urs-2GP (Glucose Protein) Urine StripsTeco Diagnostics · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940469Urine Reagent Strip-3 ParametersTeco Diagnostics1994—
+1K131600Urs-2GP (Glucose Protein) Urine StripsTeco Diagnostics2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K940469, 1994–2014Source: 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 JIL? 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 JIL device

  1. #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K131600Urs-2GP (Glucose Protein) Urine StripsTeco Diagnostics20140

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, K131600 (Teco Diagnostics, 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JIL devices

JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIL

1in 2023

2007: 32009: 12011: 12012: 12014: 12015: 12016: 22017: 12018: 42019: 12023: 1
2007high 4 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIL

187in 2018

2007: 284 days median2018: 187 days median
2007high 284 (2007) · low 187 (2018)2026

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

Recalls per year · JIL

1in 2025

2014: 42016: 12025: 1
2007high 4 (2014) · low 0 (2007)2026

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

Adverse event reports per year · JIL

15in 2025

2007: 202008: 202009: 162010: 112011: 142012: 52013: 322014: 472015: 452016: 402017: 332018: 682019: 672020: 232021: 122022: 142023: 152024: 212025: 15
2007high 68 (2018) · low 5 (2012)2025

MAUDE reports naming product code JIL, 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
20073284020
20080—020
20091—016
20100—011
20111—014
20121—05
20130—032
20141—447
20151—045
20162—140
20171—033
20184187068
20191—067
20200—023
20210—012
20220—014
20231—015
20240—021
20250—115
20260—0—

More from Teco Diagnostics

51 FDA decisions under this applicant name. See the company

  • K170118Scanostics UTI Check Application Test SystemTeco Diagnostics · 2017
  • K141289TC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt Urs-10 StripsTeco Diagnostics · 2015
  • K131600Urs-2GP (Glucose Protein) Urine StripsTeco Diagnostics · 2014
  • K111206Teco Diagnostics Saliva Alcohol TestTeco Diagnostics · 2011
  • K100024Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011

Recent decisions in JIL

The JIL category page

  • K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc. · 2023
  • K183432cobas u 601 urinalysis test systemRoche Diagnostics · 20191 recall
  • K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. · 2018
  • K180356inui In-Home Urine Analysis Test SystemScanadu, Inc. · 2018
  • K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd. · 2018

https://510kreport.com/device/K940469 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940469: Urine Reagent Strip-3 Parameters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940469

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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