Cleared Traditional

K830058 - MYOGRAPH 2000

K830058 is the FDA 510(k) clearance for MYOGRAPH 2000 by Prothia USA, Inc.. It is a Class 2 Anesthesiology device (product code BXN) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K830058 · Prothia USA, Inc. · Anesthesiology device
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Mar 1983
Decision
59d
Days
Class 2
Risk

K830058 is an FDA 510(k) clearance for the MYOGRAPH 2000. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Prothia USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory 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 Prothia USA, Inc. devices

Submission Details

510(k) Number K830058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date March 07, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BXN Stimulator, Nerve, Battery-powered

All 11
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K830058.
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · Fisher &Paykel Healthcare , Ltd. · Jul 1988
MODEL MS-II MINISTIM
K870338 · Life-Tech Intl., Inc. · Mar 1987
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · Puritan Bennett Corp. · Jun 1986
BARD BIOMEDICAL NERVE LOCATOR
K791442 · C.R. Bard, Inc. · Sep 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
K791047 · C.R. Bard, Inc. · Jun 1979
STIMULATOR, BATTERY POWERED
K790123 · Intermedics, Inc. · Feb 1979