510(k) Report

510(k) · Cleared

Cleared

Hemoglobin Electrophoresis Meth on the-

K831055510(k) TraditionalCleared Jun 8, 198368-day reviewClass II21 CFR 864.7275

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

Olympus Corp. · JBO Test, Euglobulin Lysis

Cleared on Jun 8, 1983 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 8, 1983
Review
68 days
Class
Class II
Product code
JBO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831055Source: 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.

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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 JBO devices

JBO Test, Euglobulin Lysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBO

FDA has decided no JBO device since 2007.

Median 510(k) review, days · JBO

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

Recalls per year · JBO

No recall names JBO since 2007.

Adverse event reports per year · JBO

No MAUDE report names JBO 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 Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

https://510kreport.com/device/K831055 · printed Nov 4, 2026

Cite this page

510(k) Report. “K831055: Hemoglobin Electrophoresis Meth on the-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831055

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