Cleared Traditional

K895343 - PRENATAL WEDGE

K895343 is an FDA 510(k) clearance for PRENATAL WEDGE, manufactured by Kay Ent.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K895343 · Kay Ent. · Physical Medicine device
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Sep 1989
Decision
28d
Days
Class 2
Risk

K895343 is an FDA 510(k) clearance for the PRENATAL WEDGE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Kay Ent. (Tucson, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Kay Ent. devices

FDA 510(k) Submission Details - K895343

510(k) Number K895343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date September 29, 1989
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
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 - JFB Table, Physical Therapy, Multi Function

All 33
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K895343.
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