510(k) Report

510(k) · Cleared

Cleared

Bio-Pen SRK II Calculator

K922590510(k) TraditionalCleared Aug 3, 1993427-day reviewClass III

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

Bio-Rad · LQB Medical Computers And Software For Ophthalmic Use

Cleared on Aug 3, 1993 after a 427-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 3, 1993
Review
427 days
Class
Class III
Product code
LQB
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K922590Source: 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 LQB? 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?

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 LQB devices

LQB Medical Computers And Software For Ophthalmic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQB

FDA has decided no LQB device since 2007.

Median 510(k) review, days · LQB

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

Recalls per year · LQB

No recall names LQB since 2007.

Adverse event reports per year · LQB

No MAUDE report names LQB 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—

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https://510kreport.com/device/K922590 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922590: Bio-Pen SRK II Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922590

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