510(k) Report

510(k) · Cleared

Cleared

EVT-5000BX

K952600510(k) TraditionalCleared Jun 22, 199516-day reviewClass I21 CFR 890.3760

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

U.S. Table, Inc. · INQ Table, Powered

Cleared on Jun 22, 1995 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 22, 1995
Review
16 days
Class
Class I
Product code
INQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K952600Source: 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 INQ? 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 INQ devices

INQ Table, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · INQ

FDA has decided no INQ device since 2007.

Median 510(k) review, days · INQ

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

Recalls per year · INQ

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INQ

3in 2025

2008: 12009: 52010: 22011: 22012: 32013: 12014: 22015: 62016: 22017: 42018: 22019: 32021: 12022: 32023: 12024: 12025: 3
2007high 6 (2015) · low 0 (2007)2025

MAUDE reports naming product code INQ, 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—01
20090—15
20100—02
20110—02
20120—03
20130—01
20140—02
20150—06
20160—02
20170—04
20180—02
20190—03
20200—00
20210—01
20220—03
20230—01
20240—01
20250—03
20260—0—
Cite this page

510(k) Report. “K952600: EVT-5000BX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952600

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