510(k) Report

510(k) · Cleared

Cleared

Msi Procedure Kit

K944226510(k) TraditionalCleared Jun 21, 1995295-day reviewClass II21 CFR 862.3550

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

Msi, Inc. · DOX Fluorometer, Lead (Dedicated Instruments)

Cleared on Jun 21, 1995 after a 295-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 21, 1995
Review
295 days
Class
Class II
Product code
DOX
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 K944226Source: 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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  • 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 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 DOX devices

DOX Fluorometer, Lead (Dedicated Instruments): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DOX

FDA has decided no DOX device since 2007.

Median 510(k) review, days · DOX

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

Recalls per year · DOX

No recall names DOX since 2007.

Adverse event reports per year · DOX

2in 2014

2014: 2
2007high 2 (2014) · low 0 (2007)2025

MAUDE reports naming product code DOX, 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—02
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Msi, Inc.

2 FDA decisions under this applicant name. See the company

  • K960200Introstat Lead IntroducerMsi, Inc. · 19964 recalls

Recent decisions in DOX

The DOX category page

  • K014195Kayak Hydrophilic Guide WiresBoston Scientific Corp · 2002
  • K900822Hydro-Sil (TM) Coated GuidewiresNational-Standard Medical Products · 1990
  • K832030Heparin Coated Stainless Steel/TeflonArgon Medical Corp. · 1983

https://510kreport.com/device/K944226 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944226: Msi Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944226

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