510(k) Report

510(k) · Cleared

Cleared

Reprocessed Disposable Trocars

K022743510(k) TraditionalCleared Oct 9, 200251-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

Medical Device Services · KAB Trocar, Laryngeal

Cleared on Oct 9, 2002 after a 51-day review. The FDA summary names no predicate by number.

Decided
Oct 9, 2002
Review
51 days
Class
Class I
Product code
KAB
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K022743Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KAB? 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?

The FDA summary names no predicate by number.

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 KAB devices

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

FDA decisions per year · KAB

FDA has decided no KAB device since 2007.

Median 510(k) review, days · KAB

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

Recalls per year · KAB

No recall names KAB since 2007.

Adverse event reports per year · KAB

No MAUDE report names KAB 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—

What is it indicated for?

Reprocessed trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.

Reprocessed trocars are single patient use devices.

Indications for use as stated in the FDA summary.

More from Medical Device Services

5 FDA decisions under this applicant name. See the company

  • K022753Reprocesses Used Disposable Sequential Compression Sleeves/WrapsMedical Device Services · 2002
  • K022751Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services · 2002
  • K022748Reprocssed Used Disposable Endoscopic Scissors and GraspersMedical Device Services · 2002
  • K022744Reprocessed Used Disposable Arthroscopic Blades and BursMedical Device Services · 2002

https://510kreport.com/device/K022743 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022743: Reprocessed Disposable Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022743

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026