Cleared Traditional

DILATOR, MIZUTANI LAMINARIA TENT (K782067) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K782067 · British Marketing Ent., Ltd. · Obstetrics & Gynecology device
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Jan 1979
Decision
21d
Days
Class 2
Risk

K782067 is an FDA 510(k) clearance for the DILATOR, MIZUTANI LAMINARIA TENT. Classified as Dilator, Cervical, Hygroscopic-laminaria (product code HDY), Class II - Special Controls.

Submitted by British Marketing Ent., Ltd. (Walker, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4260 - 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 British Marketing Ent., Ltd. devices

Submission Details

510(k) Number K782067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1978
Decision Date January 03, 1979
Days to Decision 21 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
139d faster than avg
Panel avg: 160d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDY Dilator, Cervical, Hygroscopic-laminaria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
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.