Cleared Traditional

K861385 - MILEX BARTHOLIN GLAND CATHETER

K861385 is an FDA 510(k) clearance for MILEX BARTHOLIN GLAND CATHETER, manufactured by Milex Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K861385 · Milex Products, Inc. · Obstetrics & Gynecology device
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Jun 1986
Decision
63d
Days
Class 2
Risk

K861385 is an FDA 510(k) clearance for the MILEX BARTHOLIN GLAND CATHETER. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Milex Products, Inc. (Chicago, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 - K861385

510(k) Number K861385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date June 16, 1986
Days to Decision 63 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 161d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 57
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K861385.
INTRAUTERINE HEMOSTASIS BALLOON STENT
K863439 · Mentor Corp. · Jun 1987
MODIFIED HYSTEROSALPINGOGRAPY SET
K871069 · Ackrad Laboratories · Apr 1987
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
K864623 · Xanmed Corp. · Jan 1987
MICROINFERTILITY NEEDLE HOLDER, TITANIUM
K844821 · Precision Surgical Instrument, Inc. · Jan 1985
MICROINFERTILITY SCISSORS, TITANIUM
K844822 · Precision Surgical Instrument, Inc. · Jan 1985
MICROINFERTILITY FORCEPS, TITANIUM
K844823 · Precision Surgical Instrument, Inc. · Jan 1985
K861385 · MILEX BARTHOLIN GLAND CATHETER
Download PDF Milex Products, Inc.