Cleared Traditional

K811614 - NERVE STIMULATOR MODEL AA 1050

K811614 is the FDA 510(k) clearance for NERVE STIMULATOR MODEL AA 1050 by Anesthesia Assoc., Inc.. It is a Class 2 Anesthesiology device (product code BXN) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K811614 · Anesthesia Assoc., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
10d
Days
Class 2
Risk

K811614 is an FDA 510(k) clearance for the NERVE STIMULATOR MODEL AA 1050. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Anesthesia Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 10 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 Anesthesia Assoc., Inc. devices

Submission Details

510(k) Number K811614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date June 18, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 8
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K811614.
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · Fisher &Paykel Healthcare , Ltd. · Jul 1988
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