510(k) Report

510(k) · Cleared

Cleared

Liquichek Spinal Fluid Control Levels I and II

K932076510(k) TraditionalCleared Jun 29, 199361-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 · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Jun 29, 1993 after a 61-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 29, 1993
Review
61 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK932076 Liquichek Spinal Fluid Control Levels I and IIBio-Rad · 1993
  2. Descendant · cites it directly · 1 of its ownK990888 Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Bio-Rad · 1999
  3. Descendant · 2 generations on · 0 of its ownK123775 Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid…Bio-Rad Laboratories · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K990888Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Bio-Rad · 1999 · cites it directly1descendant
  • K123775Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2…Bio-Rad Laboratories · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932076Liquichek Spinal Fluid Control Levels I and IIBio-Rad1993—
+1K990888Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Bio-Rad1999—
+2K123775Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level…Bio-Rad Laboratories2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201310
FIG. 1 — Lineage of K932076, 1993–2013Source: 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 JJY? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K990888Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Bio-Rad19991

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, K990888 (Bio-Rad, 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—
Cite this page

510(k) Report. “K932076: Liquichek Spinal Fluid Control Levels I and II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932076

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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