Cleared Traditional

MEDICAL SAFETY CABLE AND LEAD SYSTEM (K912415) - FDA 510(k) Clearance

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

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

Submission Details

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
62d faster than avg
Panel avg: 139d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K912415.
EarlySense Bed Sensing Unit
K171836 · Earlysense, Ltd. · Jan 2018
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · General Electric Co. · Sep 1980