510(k) Report

510(k) · Cleared

Cleared

Tonsil Sponge, Gauze Dissector, Cylindrical Sponges

K940903510(k) TraditionalCleared Apr 14, 199449-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 Insights, Inc. · KBM Dissector, Tonsil

Cleared on Apr 14, 1994 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 14, 1994
Review
49 days
Class
Class I
Product code
KBM
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K940903Source: 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 lists a 510(k) statement for it but has not posted the file, 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 KBM devices

KBM Dissector, Tonsil: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KBM

FDA has decided no KBM device since 2007.

Median 510(k) review, days · KBM

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

Recalls per year · KBM

No recall names KBM since 2007.

Adverse event reports per year · KBM

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code KBM, 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—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medical Insights, Inc.

4 FDA decisions under this applicant name. See the company

  • K940904Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze RosebudMedical Insights, Inc. · 1994
  • K940901Non-Woven SpongeMedical Insights, Inc. · 1994
  • K924958Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayMedical Insights, Inc. · 1993

https://510kreport.com/device/K940903 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940903: Tonsil Sponge, Gauze Dissector, Cylindrical Sponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940903

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