Cleared Traditional

MODEL MS-II MINISTIM (K870338) - FDA 510(k) Clearance

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

K870338 · Life-Tech Intl., Inc. · Anesthesiology device
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Mar 1987
Decision
42d
Days
Class 2
Risk

K870338 is an FDA 510(k) clearance for the MODEL MS-II 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 March 11, 1987 after a review of 42 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

Submission Details

510(k) Number K870338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date March 11, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 139d · This submission: 42d
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

Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K870338.
STIMPOD NMS450 Nerve Stimulator
K213049 · Xavant Technology (Pty), Ltd. · Oct 2022
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
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