510(k) Report

510(k) · Cleared

Cleared

Saf Fixative

K803054510(k) TraditionalCleared Dec 22, 198020-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

Remel Co. · IGB Solution, Formalin-Sodium Acetate

Cleared on Dec 22, 1980 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 22, 1980
Review
20 days
Class
Class I
Product code
IGB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K803054Source: 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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  • 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 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 IGB devices

IGB Solution, Formalin-Sodium Acetate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IGB

FDA has decided no IGB device since 2007.

Median 510(k) review, days · IGB

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

Recalls per year · IGB

No recall names IGB since 2007.

Adverse event reports per year · IGB

No MAUDE report names IGB 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 Remel Co.

137 FDA decisions under this applicant name. See the company

  • K013711Bacti-Swab DryRemel Co. · 2001
  • K965151A.C.T. IiiRemel Co. · 1997
  • K965149A.C.T. IRemel Co. · 1997
  • K965152A.C.T. IIRemel Co. · 19971 recall
  • K965150A.C.T. IVRemel Co. · 1997

https://510kreport.com/device/K803054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K803054: 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/K803054

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