Cleared Traditional

ACROTHERM (K003368) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003368 · Aquarius Medical Corp. · Cardiovascular device
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Jan 2001
Decision
81d
Days
Class 2
Risk

K003368 is an FDA 510(k) clearance for the ACROTHERM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Aquarius Medical Corp. (Scottsdale, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight 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 Aquarius Medical Corp. devices

Submission Details

510(k) Number K003368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2000
Decision Date January 19, 2001
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 32
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