510(k) Report

510(k) · Cleared

Cleared

RF Controls

K790986510(k) TraditionalCleared Jun 28, 197934-day reviewClass I21 CFR 862.3240

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

Wampole Laboratories · DMR Solution, M-Nitrophenol, Specific Reagent For Cholinesterase

Cleared on Jun 28, 1979 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 28, 1979
Review
34 days
Class
Class I
Product code
DMR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790986Source: 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 DMR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 DMR devices

DMR Solution, M-Nitrophenol, Specific Reagent For Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DMR

FDA has decided no DMR device since 2007.

Median 510(k) review, days · DMR

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

Recalls per year · DMR

No recall names DMR since 2007.

Adverse event reports per year · DMR

No MAUDE report names DMR 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 Wampole Laboratories

12 FDA decisions under this applicant name. See the company

  • K965131Borrelia Burgdorferi Igg/Igm Elisa Test SystemWampole Laboratories · 1997
  • K965129Borrelia Burgdorferi Igm Elisa Test SystemWampole Laboratories · 1997
  • K911444Rubella Virus Immunological Test SystemWampole Laboratories · 1991
  • K882896One-Step HCGWampole Laboratories · 1988
  • K883004Mono-Plus (TM)Wampole Laboratories · 1988

https://510kreport.com/device/K790986 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790986: RF Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790986

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