510(k) Report

510(k) · Cleared

Cleared

Intestoplant

K862412510(k) TraditionalCleared Nov 13, 1986141-day reviewClass II21 CFR 880.5965

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

Burron Medical Products, Inc. · LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

Cleared on Nov 13, 1986 after a 141-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 13, 1986
Review
141 days
Class
Class II
Product code
LLD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862412Source: 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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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 LLD devices

LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLD

FDA has decided no LLD device since 2007.

Median 510(k) review, days · LLD

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

Recalls per year · LLD

No recall names LLD since 2007.

Adverse event reports per year · LLD

1in 2025

2017: 32022: 12023: 12024: 12025: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code LLD, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—03
20180—00
20190—00
20200—00
20210—00
20220—01
20230—01
20240—01
20250—01
20260—0—

More from Burron Medical Products, Inc.

41 FDA decisions under this applicant name. See the company

  • K870403Cavafix (R) Central Venous Catheter Kit W/SutureBurron Medical Products, Inc. · 1987
  • K861479Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
  • K860126Stimuplex, Nerve StimulatorBurron Medical Products, Inc. · 19864 recalls
  • K851293ImplantofixBurron Medical Products, Inc. · 1986
  • K841428Jejunostomy Set for Tube FeedingBurron Medical Products, Inc. · 1984

Recent decisions in LLD

The LLD category page

  • K880072Port-a-Cath Implantable Drug Delivery SystemPharmacia Deltec, Inc. · 1988
  • K864552Port-a-Cath Implantable Catheter SystemPharmacia, Inc. · 1987
  • K832906Port-a-Cath Implantable Catheter SysPharmacia, Inc. · 1984

https://510kreport.com/device/K862412 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862412: Intestoplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862412

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