Cleared Traditional

K953205 - CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) (FDA 510(k) Clearance)

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

K953205 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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May 1996
Decision
359d
Days
Class 2
Risk

K953205 is an FDA 510(k) clearance for the CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION). Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on May 23, 1996 after a review of 359 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K953205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date May 23, 1996
Days to Decision 359 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
220d slower than avg
Panel avg: 139d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOI Stimulator, Nerve, Peripheral, Electric
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 - KOI Stimulator, Nerve, Peripheral, Electric

All 27
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