510(k) Report

510(k) · Cleared

Cleared

Jobskin Continuing Care

K925583510(k) TraditionalCleared Apr 4, 1994515-day reviewClass I21 CFR 878.4025

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

Jobst Institute, Inc. · MDA Elastomer, Silicone, For Scar Management

Cleared on Apr 4, 1994 after a 515-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 4, 1994
Review
515 days
Class
Class I
Product code
MDA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K925583Source: 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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  • 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 MDA devices

MDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDA

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDA

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

Recalls per year · MDA

No recall names MDA since 2007.

Adverse event reports per year · MDA

3in 2025

2007: 32013: 22014: 12015: 22016: 52017: 32018: 22019: 52020: 42021: 32023: 82025: 3
2007high 8 (2023) · low 0 (2008)2025

MAUDE reports naming product code MDA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—00
20091—00
20100—00
20112—00
20120—00
20130—02
20140—01
20150—02
20160—05
20170—03
20180—02
20190—05
20200—04
20210—03
20220—00
20230—08
20240—00
20250—03
20260—0—

More from Jobst Institute, Inc.

15 FDA decisions under this applicant name. See the company

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  • K925154Jobst-CustomJobst Institute, Inc. · 1994
  • K934639Jobst Athrombic Pump - System 2500Jobst Institute, Inc. · 1994
  • K922681Cutinova FoamJobst Institute, Inc. · 1992

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https://510kreport.com/device/K925583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K925583: Jobskin Continuing Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925583

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