Cleared Traditional

K982405 - MTEK-1000

K982405 is an FDA 510(k) clearance for MTEK-1000, manufactured by Magna Advanced Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K982405 · Magna Advanced Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
69d
Days
Class 2
Risk

K982405 is an FDA 510(k) clearance for the MTEK-1000. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Magna Advanced Technologies, Inc. (Miami, US). The FDA issued a Cleared decision on September 17, 1998 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Magna Advanced Technologies, Inc. devices

FDA 510(k) Submission Details - K982405

510(k) Number K982405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1998
Decision Date September 17, 1998
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 548
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K982405.
MODEL 2000 PULSE OXIMETER
K982255 · Ivy Biomedical Systems, Inc. · Oct 1998
SPO2 FINGER PROBES
K973970 · Medical Cables, Inc. · Oct 1998
MAGNATEK 40
K982907 · Magna Advanced Technologies, Inc. · Oct 1998
KELLER PULSE OXIMETER, MODEL 850+
K982331 · Keller Medical Specialties Products, Inc. · Sep 1998
AUTOCORR PLUS
K981939 · Bci Intl., Inc. · Aug 1998
OSCILLOMATE NIBP / SP02 EMS MONITOR
K980879 · Cas Medical Systems, Inc. · Jul 1998