Cleared Traditional

K881842 - TRACER

K881842 is the FDA 510(k) clearance for TRACER by Life-Tech Intl., Inc.. It is a Class 2 Anesthesiology device (product code BXN) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K881842 · Life-Tech Intl., Inc. · Anesthesiology device
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Aug 1988
Decision
121d
Days
Class 2
Risk

K881842 is an FDA 510(k) clearance for the TRACER. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on August 31, 1988 after a review of 121 days - within the typical 510(k) review window.

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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K881842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1988
Decision Date August 31, 1988
Days to Decision 121 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 140d · This submission: 121d
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 14
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K881842.
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
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