Cleared Traditional

SALTIME VISCOMETER (K936006) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K936006 · Harold J. Kosasky, M.D. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
786d
Days
Class 1
Risk

K936006 is an FDA 510(k) clearance for the SALTIME VISCOMETER. Classified as Viscometer, Mucus, Cervical (product code LHZ), Class I - General Controls.

Submitted by Harold J. Kosasky, M.D. (Chestnut Hill, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 786 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Harold J. Kosasky, M.D. devices

Submission Details

510(k) Number K936006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date February 09, 1996
Days to Decision 786 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
626d slower than avg
Panel avg: 160d · This submission: 786d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHZ Viscometer, Mucus, Cervical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.1040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.