510(k) Report

510(k) · Cleared

Cleared

Norfolk Medical Peritoneal-Access Port

K854593510(k) TraditionalCleared Feb 4, 198678-day reviewClass III

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

Norfolk Medical Products, Inc. · LMQ Device, Peritoneal Access, Subcutaneous, Implanted

Cleared on Feb 4, 1986 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 4, 1986
Review
78 days
Class
Class III
Product code
LMQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K854593Source: 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 LMQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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 LMQ devices

LMQ Device, Peritoneal Access, Subcutaneous, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMQ

FDA has decided no LMQ device since 2007.

Median 510(k) review, days · LMQ

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

Recalls per year · LMQ

No recall names LMQ since 2007.

Adverse event reports per year · LMQ

No MAUDE report names LMQ 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 Norfolk Medical Products, Inc.

20 FDA decisions under this applicant name. See the company

  • K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
  • K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  • K942784Norfolk Omega Port-LP Subcutaneously ImplantedNorfolk Medical Products, Inc. · 1995
  • K896544MD2 Personal Infusion SystemNorfolk Medical Products, Inc. · 1990

https://510kreport.com/device/K854593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854593: Norfolk Medical Peritoneal-Access Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854593

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