Cleared Traditional

K951835 - MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/...

K951835 is an FDA 510(k) clearance for MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/..., manufactured by Life Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K951835 · Life Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
113d
Days
Class 2
Risk

K951835 is an FDA 510(k) clearance for the MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITH.... Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Life Technologies, Inc. (Grand Island, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Technologies, Inc. devices

FDA 510(k) Submission Details - K951835

510(k) Number K951835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date August 11, 1995
Days to Decision 113 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 160d · This submission: 113d
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 12
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K951835.
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
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ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
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INSEMI-CATH II
K954398 · Cook Urological, Inc. · Dec 1995
INSEMI-CATH
K931630 · Cook Ob/Gyn · Apr 1994
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
K923612 · Life-Tech Intl., Inc. · Sep 1993
MODIFIED F-10 CULTURE MEDIUM
K923634 · Life-Tech Intl., Inc. · Sep 1993