Cleared Traditional

K852962 - PERIPHERAL NERVE STIMULATOR MODEL A400

K852962 is the FDA 510(k) clearance for PERIPHERAL NERVE STIMULATOR MODEL A400 by Fisher & Paykel Allied Products , Ltd.. It is a Class 2 Anesthesiology device (product code BXN) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K852962 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
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Dec 1985
Decision
150d
Days
Class 2
Risk

K852962 is an FDA 510(k) clearance for the PERIPHERAL NERVE STIMULATOR MODEL A400. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Fisher & Paykel Allied Products , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on December 9, 1985 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Allied Products , Ltd. devices

Submission Details

510(k) Number K852962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1985
Decision Date December 09, 1985
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 140d · This submission: 150d
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

All 11
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K852962.
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · Fisher &Paykel Healthcare , Ltd. · Jul 1988
MODEL MS-II MINISTIM
K870338 · Life-Tech Intl., Inc. · Mar 1987
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · Puritan Bennett Corp. · Jun 1986
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