510(k) Report

510(k) · Cleared

Cleared

Tracheostomy Cleansing Solution

K862563510(k) TraditionalCleared Jul 15, 198612-day reviewClass I21 CFR 868.5795

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

Clinipad Corp. · EPE Brush, Cleaning, Tracheal Tube

Cleared on Jul 15, 1986 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 15, 1986
Review
12 days
Class
Class I
Product code
EPE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862563Source: 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 EPE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 EPE devices

EPE Brush, Cleaning, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EPE

FDA has decided no EPE device since 2007.

Median 510(k) review, days · EPE

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

Recalls per year · EPE

No recall names EPE since 2007.

Adverse event reports per year · EPE

1in 2017

2007: 12017: 1
2007high 1 (2007) · low 0 (2008)2025

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

More from Clinipad Corp.

16 FDA decisions under this applicant name. See the company

  • K931560Cardiac Catheterization TrayClinipad Corp. · 1994
  • K931668Picc Insertion TrayClinipad Corp. · 1994
  • K932071I.V. Start KitClinipad Corp. · 1994
  • K932010V.a.D. Access KitClinipad Corp. · 1994
  • K932036Laceration TrayClinipad Corp. · 1993

Recent decisions in EPE

The EPE category page

  • K863635Updated Sterile Endotracheal BrushesBiological & Environmental Control Laboratories · 1986

https://510kreport.com/device/K862563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862563: Tracheostomy Cleansing Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862563

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