510(k) Report

510(k) · Cleared

Cleared

Continent Stoma System & Accessories

K844186510(k) TraditionalCleared Jan 15, 198578-day reviewClass I21 CFR 874.4420

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

Chesebrough-Pond'S U.S.A. Co. · KBG Trocar, Sinus

Cleared on Jan 15, 1985 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 15, 1985
Review
78 days
Class
Class I
Product code
KBG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K844186Source: 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 KBG? 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 KBG devices

KBG Trocar, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KBG

FDA has decided no KBG device since 2007.

Median 510(k) review, days · KBG

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

Recalls per year · KBG

No recall names KBG since 2007.

Adverse event reports per year · KBG

1in 2020

2013: 12020: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code KBG, 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—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Chesebrough-Pond'S U.S.A. Co.

33 FDA decisions under this applicant name. See the company

  • K863866Respiradyne II (TM)Chesebrough-Pond'S U.S.A. Co. · 1987
  • K862803Chesebrough Pond's Hydrocolloid DressingChesebrough-Pond'S U.S.A. Co. · 1986
  • K851382Chesebrough-Pond's Sequential Wound DressingChesebrough-Pond'S U.S.A. Co. · 1985
  • K851383Blisterfilm Transparent DressingChesebrough-Pond'S U.S.A. Co. · 1985
  • K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985

Recent decisions in KBG

The KBG category page

  • K033591Reprocessed TrocarsClearmedical, Inc. · 2005
  • K013987Reprocessed Disposable TrocarsAdven Medical · 2002

https://510kreport.com/device/K844186 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844186: Continent Stoma System & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844186

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