Cleared Traditional

K984306 - `THE INSEMINATOR' (PROPOSED)

K984306 is an FDA 510(k) clearance for `THE INSEMINATOR' (PROPOSED), manufactured by Wallach Surgical Devices, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K984306 · Wallach Surgical Devices, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
89d
Days
Class 2
Risk

K984306 is an FDA 510(k) clearance for the `THE INSEMINATOR' (PROPOSED). Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 89 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.

View all Wallach Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K984306

510(k) Number K984306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date March 01, 1999
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
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 19
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K984306.
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · Medworks Corp. · Jan 1999
MEDWORKS INSEMINATION CATHETER
K982628 · Medworks Corp. · Aug 1998
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
K980061 · Rocket Medical Plc · Mar 1998
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · A & A Medical, Inc. · Oct 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · A & A Medical, Inc. · Aug 1997
MICROSPAN INSEMINATION SYSTEM
K970750 · Imagyn Medical, Inc. · May 1997