510(k) Report

510(k) · Cleared

Cleared

Oxalate Reagent

K883525510(k) TraditionalCleared Oct 25, 198869-day reviewClass I21 CFR 862.1542

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

Sigma Chemical Co. · LPW System, Test, Oxalate

Cleared on Oct 25, 1988 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 25, 1988
Review
69 days
Class
Class I
Product code
LPW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K883525Source: 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 LPW devices

LPW System, Test, Oxalate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPW

FDA has decided no LPW device since 2007.

Median 510(k) review, days · LPW

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

Recalls per year · LPW

No recall names LPW since 2007.

Adverse event reports per year · LPW

No MAUDE report names LPW 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 Sigma Chemical Co.

231 FDA decisions under this applicant name. See the company

  • K933694Sigma Glucose ReagentSigma Chemical Co. · 1994
  • K933678Sigma Calcium ReagentSigma Chemical Co. · 1994
  • K933696Sigma Electrolyte Reference ReagentSigma Chemical Co. · 1994
  • K933691Sigma CO2 Alkaline Buffer ReagentSigma Chemical Co. · 1993
  • K933679Sigma Bun ReagentSigma Chemical Co. · 1993

https://510kreport.com/device/K883525 · printed Nov 4, 2026

Cite this page

510(k) Report. “K883525: Oxalate Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883525

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