Cleared Traditional

K894489 - GYNECOLOGIC EXAMINATION KIT

K894489 is the FDA 510(k) clearance for GYNECOLOGIC EXAMINATION KIT by A & A Medical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K894489 · A & A Medical, Inc. · Obstetrics & Gynecology device
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Oct 1989
Decision
77d
Days
Class 2
Risk

K894489 is an FDA 510(k) clearance for the GYNECOLOGIC EXAMINATION KIT. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on October 5, 1989 after a review of 77 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.

View all A & A Medical, Inc. devices

Submission Details

510(k) Number K894489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 05, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 160d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIB Speculum, Vaginal, Nonmetal
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 - HIB Speculum, Vaginal, Nonmetal

All 11
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K894489.
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · Cabot Medical Corp. · Jun 1994
DISPOSABLE PLASTIC VAGINAL SPECULA
K926536 · Thomasville Medical Assoc. · Feb 1994
DISPOSABLE PLASTIC VAGINAL SPECULA
K894957 · Zinnanti Surgical Instruments, Inc. · Oct 1989
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
K882605 · Buckman Co., Inc. · Sep 1988