510(k) Report

510(k) · Cleared

Cleared

Benson CCA100

K924652510(k) TraditionalCleared Apr 9, 1993206-day reviewClass II21 CFR 874.4500

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

Benson Medical Instruments Co. · EWG Laser, Ent Microsurgical Carbon-Dioxide

Cleared on Apr 9, 1993 after a 206-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 9, 1993
Review
206 days
Class
Class II
Product code
EWG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K924652Source: 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 EWG? 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 EWG devices

EWG Laser, Ent Microsurgical Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EWG

FDA has decided no EWG device since 2007.

Median 510(k) review, days · EWG

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

Recalls per year · EWG

No recall names EWG since 2007.

Adverse event reports per year · EWG

1in 2022

2009: 12010: 12014: 12018: 12019: 22020: 12021: 12022: 1
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code EWG, 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—01
20100—01
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—01
20190—02
20200—01
20210—01
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Benson Medical Instruments Co.

5 FDA decisions under this applicant name. See the company

  • K123896CCS-200 SpirometerBenson Medical Instruments Co. · 2013
  • K982441CCA-220Benson Medical Instruments Co. · 1998
  • K981439CCA-200Benson Medical Instruments Co. · 1998
  • K963681Cca-100 (Modified)Benson Medical Instruments Co. · 1996

Recent decisions in EWG

The EWG category page

  • K870587Lasermatic Surgilaser Model 5050Lasermatic OY · 1988
  • K880429Illumina 55 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K880427Illumina 40 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K880428Illumina 25 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K872710Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatDirected Energy, Inc. · 1987

https://510kreport.com/device/K924652 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924652: Benson CCA100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924652

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