Cleared Traditional

K915353 - MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP

K915353 is an FDA 510(k) clearance for MATRX MEDICAL MAXIMIZER 1000 AND 2000 V..., manufactured by Matrix Medica, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K915353 · Matrix Medica, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
31d
Days
Class 1
Risk

K915353 is an FDA 510(k) clearance for the MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on December 27, 1991 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory 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.

FDA 510(k) Submission Details - K915353

510(k) Number K915353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date December 27, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 128d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K915353.
CLEAN UP
K922985 · Bio-Probe, Inc. · May 1993
WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM
K925829 · Waggoner Dental Mfg. · Feb 1993
AIR MEDICA III
K920710 · Hinatawada Seimitsu Mfg. Co., Ltd. · May 1992
STOMAVISION (STV)
K913464 · Trophy Radiologie · Nov 1991
MDT/CASTLE PURUS DENTAL UNIT
K914697 · Mdt Corp., Inc. · Nov 1991
ORALCAM
K911594 · Charmac Group, Inc. · Jul 1991
K915353 · MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP
Download PDF Matrix Medica, Inc.