Cleared Traditional

K890548 - AQUACISER SYSTEM

K890548 is an FDA 510(k) clearance for AQUACISER SYSTEM, manufactured by Aquaciser, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K890548 · Aquaciser, Inc. · Physical Medicine device
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Feb 1989
Decision
10d
Days
Class 2
Risk

K890548 is an FDA 510(k) clearance for the AQUACISER SYSTEM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Aquaciser, Inc. (Chicago, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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.

View all Aquaciser, Inc. devices

FDA 510(k) Submission Details - K890548

510(k) Number K890548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date February 13, 1989
Days to Decision 10 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILJ Device Classification - Class 2, Special Controls

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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 - ILJ Bath, Hydro-massage

All 13
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K890548.
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
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K971593 · The Silcraft Corp. · Feb 1998
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K964926 · Joerns Healthcare, Inc. · Nov 1997