Cleared Traditional

PHEM-CHEK (K960648) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K960648 · Femtek, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
89d
Days
Class 1
Risk

K960648 is an FDA 510(k) clearance for the PHEM-CHEK. Classified as Paper, Obstetric Ph (product code LNW), Class I - General Controls.

Submitted by Femtek, Inc. (Pasadena, US). The FDA issued a Cleared decision on May 13, 1996 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 862.1550 - 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 Femtek, Inc. devices

Submission Details

510(k) Number K960648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1996
Decision Date May 13, 1996
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LNW Paper, Obstetric Ph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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.