Cleared Traditional

PHEM-ALERT (K032161) - FDA 510(k) Clearance

Class I Chemistry device.

K032161 · Femtek,Llc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
77d
Days
Class 1
Risk

K032161 is an FDA 510(k) clearance for the PHEM-ALERT. Classified as Paper, Obstetric Ph (product code LNW), Class I - General Controls.

Submitted by Femtek,Llc. (Rockville, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - the FDA in vitro diagnostics and chemistry 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,Llc. devices

Submission Details

510(k) Number K032161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2003
Decision Date September 30, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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.