Cleared Traditional

K923037 - MILES SODIUM METHOD

K923037 is the FDA 510(k) clearance for MILES SODIUM METHOD by Heraeus Kulzer, Inc.. It is a Class 2 Chemistry device (product code JOS) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K923037 · Heraeus Kulzer, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
95d
Days
Class 2
Risk

K923037 is an FDA 510(k) clearance for the MILES SODIUM METHOD. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 878.4400 - 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K923037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1992
Decision Date September 22, 1992
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - JOS Electrode, Electrosurgical

All 20
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K923037.
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · Aaron Medical Industries · May 1995
ELECTRODES
K944992 · Linvatec Corp. · Apr 1995
ELECTRODE EXTENDER
K905060 · Megadyne Medical Products, Inc. · Apr 1991
ELECTRODE, ELECTROSURGERY
K903302 · Megadyne Medical Products, Inc. · Oct 1990
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989