510(k) Report

510(k) · Cleared

Cleared

Coulter Viscometer II

K883503510(k) TraditionalCleared Sep 19, 198833-day reviewClass I21 CFR 862.2920

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

Coulter Electronics, Inc. · JJL Plasma Viscometer For Clinical Use

Cleared on Sep 19, 1988 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 19, 1988
Review
33 days
Class
Class I
Product code
JJL
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K883503Source: FDA 510(k) database · 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 JJL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All JJL devices

JJL Plasma Viscometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJL

FDA has decided no JJL device since 2007.

Median 510(k) review, days · JJL

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

Recalls per year · JJL

No recall names JJL since 2007.

Adverse event reports per year · JJL

No MAUDE report names JJL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Coulter Electronics, Inc.

101 FDA decisions under this applicant name. See the company

  • K923951CD8 Cytospheres KitCoulter Electronics, Inc. · 1994
  • K930119Coulter Retic-C Cell ControlCoulter Electronics, Inc. · 1993
  • K921279CD4 Cytospheres KitCoulter Electronics, Inc. · 1992
  • K923530Coulter Multi-Q-PrepCoulter Electronics, Inc. · 1992
  • K922181Coulter MH009Coulter Electronics, Inc. · 1992

https://510kreport.com/device/K883503 · printed Nov 4, 2026

Cite this page

510(k) Report. “K883503: Coulter Viscometer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883503

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026