510(k) Report

510(k) · Cleared

Cleared

Lyphochek Quantitative Urine Control Normal (1)

K880496510(k) TraditionalCleared Mar 16, 198841-day reviewClass I21 CFR 862.1660

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

Bio-Rad · JJW Urinalysis Controls (Assayed And Unassayed)

Cleared on Mar 16, 1988 after a 41-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
Mar 16, 1988
Review
41 days
Class
Class I
Product code
JJW
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK880496 Lyphochek Quantitative Urine Control Normal (1)Bio-Rad · 1988
  2. Descendant · cites it directly · 0 of its ownK992576 Urine Chemistry Control, Level 1Consolidated Technologies, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K992576Urine Chemistry Control, Level 1Consolidated Technologies, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880496Lyphochek Quantitative Urine Control Normal (1)Bio-Rad1988—
+1K992576Urine Chemistry Control, Level 1Consolidated Technologies, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K880496, 1988–1999Source: 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 JJW? 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?

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
K992576Urine Chemistry Control, Level 1Consolidated Technologies, Inc.19990

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, K992576 (Consolidated Technologies, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJW devices

JJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJW

1in 2017

2007: 22009: 12011: 22014: 12015: 12017: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJW

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

Recalls per year · JJW

2in 2024

2007: 12012: 72013: 12022: 22024: 2
2007high 7 (2012) · low 0 (2008)2026

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

Adverse event reports per year · JJW

1in 2022

2007: 22009: 12012: 12013: 242022: 1
2007high 24 (2013) · low 0 (2008)2025

MAUDE reports naming product code JJW, 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
20072—12
20080—00
20091—01
20100—00
20112—00
20120—71
20130—124
20141—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—21
20230—00
20240—20
20250—00
20260—0—

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Recent decisions in JJW

The JJW category page

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https://510kreport.com/device/K880496 · printed Nov 5, 2026

Cite this page

510(k) Report. “K880496: Lyphochek Quantitative Urine Control Normal (1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K880496

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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