Cleared Traditional

ISE/NA+ (K912648) - FDA 510(k) Clearance

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

K912648 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
30d
Days
Class 2
Risk

K912648 is an FDA 510(k) clearance for the ISE/NA+. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K912648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date July 17, 1991
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 43
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