Cleared Traditional

NANOSEP N10 (K935496) - FDA 510(k) Clearance

Class I Chemistry device.

K935496 · Intersep , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
162d
Days
Class 1
Risk

K935496 is an FDA 510(k) clearance for the NANOSEP N10. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Intersep , Ltd. (England, GB). The FDA issued a Cleared decision on April 26, 1994 after a review of 162 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2310 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Intersep , Ltd. devices

Submission Details

510(k) Number K935496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date April 26, 1994
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
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.