510(k) Report

510(k) · Cleared

Cleared

Jar Holder & Opener

K813631510(k) TraditionalCleared Jan 19, 198221-day reviewClass I21 CFR 890.5050

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

Fred Sammons, Inc. · IKW Utensil, Homemaking

Cleared on Jan 19, 1982 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 19, 1982
Review
21 days
Class
Class I
Product code
IKW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared19801990200020102020
  1. This deviceK813631 Jar Holder & OpenerFred Sammons, Inc. · 1982
  2. Descendant · cites it directly · 0 of its ownK121661 EZ-Assist-FillAssist Fill, LLC · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K121661EZ-Assist-FillAssist Fill, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K813631Jar Holder & OpenerFred Sammons, Inc.1982—
+1K121661EZ-Assist-FillAssist Fill, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K813631, 1982–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121661EZ-Assist-FillAssist Fill, LLC20120

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.

What does this lineage say?

  • Of its descendants, K121661 (Assist Fill, LLC, 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IKW devices

IKW Utensil, Homemaking: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKW

FDA has decided no IKW device since 2007.

Median 510(k) review, days · IKW

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

Recalls per year · IKW

No recall names IKW since 2007.

Adverse event reports per year · IKW

No MAUDE report names IKW 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—
Cite this page

510(k) Report. “K813631: Jar Holder & Opener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K813631

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