510(k) · Cleared

Cleared

Select Iui

K954099510(k) TraditionalCleared Nov 22, 199583-day reviewClass II21 CFR 884.5250

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

Select Medical Systems, Inc. · MFD Cannula, Intrauterine Insemination

Cleared on Nov 22, 1995 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Nov 22, 1995
Review: 83 days
Class: Class II
Product code: MFD
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK954099 Select IuiSelect Medical Systems, Inc. · 1995
Descendant · cites it directly · 0 of its ownK143669 MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn…Medgyn Products, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K143669MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterMedgyn Products, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954099	Select Iui	Select Medical Systems, Inc.	1995	—
+1	K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini…	Medgyn Products, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K954099, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MFD? 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

Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter	Medgyn Products, Inc.	2015	0

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.

What does this lineage say?

Of its descendants, K143669 (Medgyn Products, Inc., 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MFD devices

MFD Cannula, Intrauterine Insemination: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MFD

FDA has decided no MFD device since 2007.

Median 510(k) review, days · MFD

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

Recalls per year · MFD

No recall names MFD since 2007.

Adverse event reports per year · MFD

1in 2022

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code MFD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K954099 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954099: Select Iui.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954099

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026