Cleared Traditional

PROLONG, MODELS PL50, PL100, PL150 (K001129) - FDA 510(k) Clearance

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

K001129 · Life-Tech Intl., Inc. · Anesthesiology device
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Jul 2000
Decision
90d
Days
Class 2
Risk

K001129 is an FDA 510(k) clearance for the PROLONG, MODELS PL50, PL100, PL150. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Stafford, US). The FDA issued a Cleared decision on July 6, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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 K001129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date July 06, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - CAZ Anesthesia Conduction Kit

All 26
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K001129.
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282 · B.Braun Medical, Inc. · Jun 2007
PERIFIX CATHETER CONNECTOR
K033952 · B.Braun Medical, Inc. · Feb 2004
PERIFIX CATHETER CONNECTOR
K032144 · B.Braun Medical, Inc. · Oct 2003
SOFT TIP EPIDURAL CATHETER KIT
K971233 · B.Braun Medical, Inc. · Oct 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696 · B.Braun Medical, Inc. · Apr 1997
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880 · Sherwood Medical Co. · Dec 1996