Cleared Traditional

K914164 - VITALMAX 840 SERIES

K914164 is an FDA 510(k) clearance for VITALMAX 840 SERIES, manufactured by Pace Tech Medical Monitors, Inc.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 570-day FDA review.

K914164 · Pace Tech Medical Monitors, Inc. · Anesthesiology device
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Apr 1993
Decision
570d
Days
Class 2
Risk

K914164 is an FDA 510(k) clearance for the VITALMAX 840 SERIES. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Pace Tech Medical Monitors, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 9, 1993 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K914164

510(k) Number K914164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date April 09, 1993
Days to Decision 570 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
430d slower than avg
Panel avg: 140d · This submission: 570d
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 37
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K914164.
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · Te ME NA S.A.R.L. · Sep 2001
STIMUPLEX HNS-11
K003983 · Stockert GmbH · Jun 2001
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
MS-III MINISTIM
K913184 · Life-Tech Intl., Inc. · Oct 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991
MYOTRACK, MODEL HH 515
K904025 · Myotrack Co. · Mar 1991
K914164 · VITALMAX 840 SERIES
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