Cleared Traditional

K913184 - MS-III MINISTIM

K913184 is an FDA 510(k) clearance for MS-III MINISTIM, manufactured by Life-Tech Intl., Inc.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K913184 · Life-Tech Intl., Inc. · Anesthesiology device
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Oct 1991
Decision
81d
Days
Class 2
Risk

K913184 is an FDA 510(k) clearance for the MS-III MINISTIM. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 81 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 Life-Tech Intl., Inc. devices

FDA 510(k) Submission Details - K913184

510(k) Number K913184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date October 07, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXN Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K913184.
MULTISTIM
K011308 · Pajunk GmbH · Nov 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · Te ME NA S.A.R.L. · Sep 2001
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
K883868 · Fisher & Paykel Electronics , Ltd. · Nov 1988
TRACER
K881842 · Life-Tech Intl., Inc. · Aug 1988