Cleared Traditional

SANITAS WHIRPOOL BATHING SYSTEM (K930624) - FDA 510(k) Clearance

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

K930624 · Dutton-Lainson Co. · Physical Medicine device
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Jul 1994
Decision
508d
Days
Class 2
Risk

K930624 is an FDA 510(k) clearance for the SANITAS WHIRPOOL BATHING SYSTEM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Dutton-Lainson Co. (Hastings, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Dutton-Lainson Co. devices

Submission Details

510(k) Number K930624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date July 01, 1994
Days to Decision 508 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 115d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.