510(k) Report

510(k) · Cleared

Cleared

Saf Fixative

K831058510(k) TraditionalCleared Jun 8, 198368-day reviewClass I21 CFR 864.4010

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

American Micro Scan · LDW Fixative, Acid Containing

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 I
Product code
LDW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831058Source: 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 LDW? 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 LDW devices

LDW Fixative, Acid Containing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDW

FDA has decided no LDW device since 2007.

Median 510(k) review, days · LDW

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

Recalls per year · LDW

No recall names LDW since 2007.

Adverse event reports per year · LDW

No MAUDE report names LDW 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 American Micro Scan

36 FDA decisions under this applicant name. See the company

  • K870029Immunoscan (TM) Direct Streptococcus PneumoniaeAmerican Micro Scan · 1987
  • K864662Chlamydiae Fluor. AB Test for Detection in SmearsAmerican Micro Scan · 1987
  • K863776Microdilution Mic PanelsAmerican Micro Scan · 1987
  • K864674Microdilution Identification PanelsAmerican Micro Scan · 1987
  • K864389Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 1986

Recent decisions in LDW

The LDW category page

  • K883062Ats Schaudinn's Fixative W/Acetic AcidAlpha-Tec Systems, Inc. · 1988
  • K842923Picric Acid 1% W/VE K Ind., Inc. · 1984
  • K842922Picric Acid Saturated SolutionE K Ind., Inc. · 1984

https://510kreport.com/device/K831058 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831058: Saf Fixative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831058

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