Cleared Traditional

K811438 - ACRATRAC R

K811438 is an FDA 510(k) clearance for ACRATRAC R, manufactured by Avratronics Corp.. The device is a Class 1 Physical Medicine device with product code INW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811438 · Avratronics Corp. · Physical Medicine device
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Jun 1981
Decision
18d
Days
Class 1
Risk

K811438 is an FDA 510(k) clearance for the ACRATRAC R. Classified as Table, Mechanical (product code INW), Class I - General Controls.

Submitted by Avratronics Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3750 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K811438

510(k) Number K811438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 09, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 116d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

INW Device Classification - Class 1, General Controls

Product Code INW Table, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3750
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 - INW Table, Mechanical

All 34
Devices cleared under the same product code (INW) and FDA review panel - the closest regulatory comparables to K811438.
SCHOOLTABLE
K862894 · Mednet, Inc. · Aug 1986
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
K861350 · Tri W-G, Inc. · May 1986
OB TILT TABLE
K823149 · Orthion Corp. · Nov 1982
MECHANICAL TABLE
K810445 · Fred Sammons, Inc. · Mar 1981
TRITON
K801643 · Chattanooga Group, Inc. · Jul 1980
MILLER TABLE
K780531 · Victor John Manley · Apr 1978
K811438 · ACRATRAC R
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