Cleared Traditional

K853303 - LIFELINC LEADWIRE

K853303 is an FDA 510(k) clearance for LIFELINC LEADWIRE, manufactured by Tronomed, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K853303 · Tronomed, Inc. · Anesthesiology device
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Sep 1985
Decision
43d
Days
Class 2
Risk

K853303 is an FDA 510(k) clearance for the LIFELINC LEADWIRE. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Tronomed, Inc. (Irvine, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Tronomed, Inc. devices

FDA 510(k) Submission Details - K853303

510(k) Number K853303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1985
Decision Date September 18, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 102
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K853303.
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · Clinical Data, Inc. · Oct 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · Edentec Corp. · Jul 1985
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985