510(k) Report

510(k) · Cleared

Recalled · 2007

Synovialscopics, Synovial Fluid Control

K010598510(k) TraditionalCleared Mar 23, 200123-day reviewClass II21 CFR 864.8625Recalls 1

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

Quantimetrix Corp. · JPK Mixture, Hematology Quality Control

Cleared on Mar 23, 2001 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Mar 23, 2001
Review
23 days
Class
Class II
Product code
JPK
Recalls
1
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK010598 Synovialscopics, Synovial Fluid ControlQuantimetrix Corp. · 2001
  2. Descendant · cites it directly · 0 of its ownK041240 Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010598Synovialscopics, Synovial Fluid ControlQuantimetrix Corp.2001—
+1K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K010598, 2001–2004Source: 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 JPK? 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
K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc.20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 1, 2007Not classifiedZ-0516-2009Employee errorThis recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K041240 (Fertility Solutions, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPK

4in 2016

2007: 52009: 52010: 42011: 12012: 22013: 12014: 22016: 4
2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007: 44 days median2009: 187 days median2010: 267 days median2016: 296 days median
2007high 296 (2016) · low 44 (2007)2026

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

Recalls per year · JPK

1in 2022

2007: 12010: 22011: 32012: 12020: 12021: 22022: 1
2007high 3 (2011) · low 0 (2008)2026

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

Adverse event reports per year · JPK

2in 2023

2007: 142008: 12010: 52011: 562012: 22014: 12019: 12020: 12021: 12023: 2
2007high 56 (2011) · low 0 (2009)2025

MAUDE reports naming product code JPK, 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
2007544114
20080—01
2009518700
2010426725
20111—356
20122—12
20131—00
20142—01
20150—00
2016429600
20170—00
20180—00
20190—01
20200—11
20210—21
20220—10
20230—02
20240—00
20250—00
20260—0—

More from Quantimetrix Corp.

38 FDA decisions under this applicant name. See the company

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  • K103744Dropper A1C Diabetes ControlQuantimetrix Corp. · 2011
  • K062942Quantimetrix Nicosure Cotinine Urine ControlQuantimetrix Corp. · 2006
  • K062751Modification to Quantimetrix Cardiasure Cardiac MarkerQuantimetrix Corp. · 2006

Recent decisions in JPK

The JPK category page

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https://510kreport.com/device/K010598 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010598: Synovialscopics, Synovial Fluid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010598

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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