Cleared Traditional

K974395 - ATLANT'S

K974395 is an FDA 510(k) clearance for ATLANT'S, manufactured by Grad-Line Corp.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K974395 · Grad-Line Corp. · Physical Medicine device
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Oct 1998
Decision
335d
Days
Class 2
Risk

K974395 is an FDA 510(k) clearance for the ATLANT'S. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Grad-Line Corp. (Deerfield, US). The FDA issued a Cleared decision on October 22, 1998 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K974395

510(k) Number K974395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date October 22, 1998
Days to Decision 335 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 116d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K974395.
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K964957 · Eischoco, Inc. · Feb 1997
BIO BOOST
K961426 · Bio Compression Systems, Inc. · Oct 1996
MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP
K953516 · Yoav Gershoni · Dec 1995
K974395 · ATLANT'S
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