Cleared Traditional

K954099 - SELECT IUI

K954099 is an FDA 510(k) clearance for SELECT IUI, manufactured by Select Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954099 · Select Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
83d
Days
Class 2
Risk

K954099 is an FDA 510(k) clearance for the SELECT IUI. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K954099

510(k) Number K954099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date November 22, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 161d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MFD Cannula, Intrauterine Insemination

All 28
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K954099.
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
K962273 · Marlo Surgical Technology · Jul 1996
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · Ackrad Laboratories · Apr 1996
INSEMI-CATH II
K954398 · Cook Urological, Inc. · Dec 1995
HUMAN TUBAL FLUID
K953719 · Life Technologies, Inc. · Nov 1995
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE
K951835 · Life Technologies, Inc. · Aug 1995
INTRAUTERINE CATHETER AND INTRODUCER
K932993 · Conceptus, Inc. · Jan 1995
K954099 · SELECT IUI
Download PDF FDA Summary Select Medical System…