Cleared Traditional

K012057 - CASCADE BATH, MODEL 6900

K012057 is an FDA 510(k) clearance for CASCADE BATH, manufactured by Penner Manufacturing, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K012057 · Penner Manufacturing, Inc. · Physical Medicine device
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Jul 2001
Decision
17d
Days
Class 2
Risk

K012057 is an FDA 510(k) clearance for the CASCADE BATH, MODEL 6900. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Penner Manufacturing, Inc. (Ohaha, US). The FDA issued a Cleared decision on July 19, 2001 after a review of 17 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.

FDA 510(k) Submission Details - K012057

510(k) Number K012057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date July 19, 2001
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 116d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
BRIAN R BIERSACH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ILJ Bath, Hydro-massage

All 59
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K012057.
IMMERSION HYDROBATH
K082951 · Arjo Hospital Equipment AB · Apr 2009
MBATH 1000 (60)
K052479 · Enneking Medical, Inc. · Jan 2006
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
K040772 · Penner Manufacturing, Inc. · Apr 2004
SUPERIOR BATH, MODEL 6300
K012061 · Penner Manufacturing, Inc. · Jul 2001
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K001079 · Arjo, Inc. · May 2000
VANNA BATHING SYSTEM
K993872 · Vancare, Inc. · Feb 2000

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K012057 · CASCADE BATH, MODEL 6900
Download PDF Penner Manufacturing,…