510(k) Report

510(k) · Cleared

Cleared

Hemastix Reagent Strips

K905396510(k) TraditionalCleared Feb 11, 199173-day reviewClass II21 CFR 864.6550

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

Heraeus Kulzer, Inc. · JIO Blood, Occult, Colorimetric, In Urine

Cleared on Feb 11, 1991 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Feb 11, 1991
Review
73 days
Class
Class II
Product code
JIO
Recalls
None
Predicates
0

24 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2023: 2 descendants cleared2015: 2 descendants cleared2012: 1 descendant cleared2018: 2 descendants cleared2016: 2 descendants cleared2024: 1 descendant cleared2019: 1 descendant cleared2025: 3 descendants cleared2022: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
  2. Descendant · cites it directly · 16 of its ownK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
  3. Descendant · 2 generations on · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
  4. Descendant · cites it directly · 4 of its ownK100024 Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011
  5. Descendant · 2 generations on · 3 of its ownK231045 Healgen URS Test StripsHealgen Scientific,, LLC · 2023
  6. Descendant · 2 generations on · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 22009: 12011: 22012: 12014: 12015: 22016: 22018: 22019: 12022: 12023: 22024: 12025: 32026: 1
2003high 3 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 24 · See all
  • K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003 · cites it directly16descendants
  • K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · 2 generations on6descendants
  • K100024Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011 · cites it directly4descendants
  • K231045Healgen URS Test StripsHealgen Scientific,, LLC · 2023 · 2 generations on3descendants
  • K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905396Hemastix Reagent StripsHeraeus Kulzer, Inc.1991—
+1K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC2003—
+2K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics20094
+1K100024Teco Diagnostics Uti Detection StripsTeco Diagnostics2011—
+2K231045Healgen URS Test StripsHealgen Scientific,, LLC2023—
+2K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200720
200910
201120
201210
201410
201520
201620
201820
201910
202210
202320
202410
202530
202610
FIG. 1 — Lineage of K905396, 1991–2026Source: 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 JIO? 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 JIO device

  1. #1 K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA…score 8.5 · 5 generations · no Class I recall
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? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC200316
K100024Teco Diagnostics Uti Detection StripsTeco Diagnostics20114
K063295Acon Uti Urinary Tract Infection Test StripsACON Laboratories, Inc.20070
K061559Acon Urinalysis Reagent StripsAcon Laboratories Co.20060

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, K031947 (Bayer Healthcare, LLC, 2003) has gone furthest, with 16 descendants of its own.

How does its category compare?

All JIO devices

JIO Blood, Occult, Colorimetric, In Urine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIO

1in 2024

2009: 22012: 22024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIO

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

Recalls per year · JIO

No recall names JIO since 2007.

Adverse event reports per year · JIO

1in 2025

2008: 22009: 12011: 12012: 12013: 32014: 42015: 12024: 12025: 1
2007high 4 (2014) · low 0 (2007)2025

MAUDE reports naming product code JIO, 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—00
20080—02
20092—01
20100—00
20110—01
20122—01
20130—03
20140—04
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—01
20250—01
20260—0—

More from Heraeus Kulzer, Inc.

145 FDA decisions under this applicant name. See the company

  • K091494Flexitime FlowHeraeus Kulzer, Inc. · 2009
  • K063062Hkbond 2006Heraeus Kulzer, Inc. · 2006
  • K060994MondialHeraeus Kulzer, Inc. · 2006
  • K052543Heraceram ZirkoniaHeraeus Kulzer, Inc. · 2005
  • K043504PalaimpactHeraeus Kulzer, Inc. · 2005

Recent decisions in JIO

The JIO category page

  • K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd. · 2024
  • K111999Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent…Healgen Scientific,, LLC · 20121 recall
  • K111221Mission U500 Urine AnalyzerACON Laboratories, Inc. · 2012
  • K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009
  • K083724Wiener Lab. Urine Strip 10 and 11Wiener Laboratorios Saic · 2009

https://510kreport.com/device/K905396 · printed Nov 3, 2026

Cite this page

510(k) Report. “K905396: Hemastix Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905396

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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