Cleared Traditional

K971100 - ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR

K971100 is an FDA 510(k) clearance for ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR, manufactured by Atrion Medical Products, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K971100 · Atrion Medical Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
58d
Days
Class 1
Risk

K971100 is an FDA 510(k) clearance for the ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 58 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 - K971100

510(k) Number K971100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date May 23, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 128d · This submission: 58d
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 244
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