Cleared Traditional

K912415 - MEDICAL SAFETY CABLE AND LEAD SYSTEM

K912415 is an FDA 510(k) clearance for MEDICAL SAFETY CABLE AND LEAD SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K912415 · Medtronic Vascular · Anesthesiology device
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Aug 1991
Decision
77d
Days
Class 2
Risk

K912415 is an FDA 510(k) clearance for the MEDICAL SAFETY CABLE AND LEAD SYSTEM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 77 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K912415

510(k) Number K912415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date August 16, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 105
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K912415.
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819 · Edentec Corp. · Oct 1993
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749 · Edentec Corp. · Jul 1992
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · Edentec Corp. · Jun 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · Synectics-Dantec · Apr 1991
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020 · Aequitron Medical, Inc. · Apr 1991