Cleared Traditional

K921498 - VER MED A10011 PNS DUAL ELEMENT ELECTRODE (FDA 510(k) Clearance)

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

K921498 · Vermont Medical, Inc. · Anesthesiology device
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Jun 1993
Decision
435d
Days
Class 2
Risk

K921498 is an FDA 510(k) clearance for the VER MED A10011 PNS DUAL ELEMENT ELECTRODE. Classified as Stimulator, Nerve, Ac-powered (product code BXM), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 435 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.

View all Vermont Medical, Inc. devices

Submission Details

510(k) Number K921498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date June 09, 1993
Days to Decision 435 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 139d · This submission: 435d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXM Stimulator, Nerve, Ac-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.