Cleared Traditional

K843869 - TRANQUILITY

K843869 is an FDA 510(k) clearance for TRANQUILITY, manufactured by Principle Business Ent.. The device is a Class 1 Gastroenterology & Urology device with product code EYQ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K843869 · Principle Business Ent. · Gastroenterology & Urology device
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Nov 1984
Decision
45d
Days
Class 1
Risk

K843869 is an FDA 510(k) clearance for the TRANQUILITY. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Principle Business Ent. (Dunbridge, US). The FDA issued a Cleared decision on November 16, 1984 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5920 - the FDA gastroenterology and urology 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 Principle Business Ent. devices

FDA 510(k) Submission Details - K843869

510(k) Number K843869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date November 16, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 131d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

EYQ Device Classification - Class 1, General Controls

Product Code EYQ Garment, Protective, For Incontinence
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EYQ Garment, Protective, For Incontinence

All 22
Devices cleared under the same product code (EYQ) and FDA review panel - the closest regulatory comparables to K843869.
ADULT DISPOS. INCONTINENT PANTS
K850153 · Convatec, A Division of E.R. Squibb & Sons · Feb 1985
DIGNITY PANT & ABSORBENT PADS
K850154 · Convatec, A Division of E.R. Squibb & Sons · Feb 1985
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
K845010 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
ULTRA SHIELD BRIEFS
K841953 · Ipco Corp. · Jul 1984
AMBEZE DISPOSABLE INCONTINENCE PANTS
K840753 · Ipco Corp. · Apr 1984
MAXISHIELD INCONTINENCE CARE SYSTEM
K840754 · Ipco Corp. · Apr 1984