Cleared Traditional

K892888 - EXTACISER PERINEAL MUSCLE EXERCISER

K892888 is an FDA 510(k) clearance for EXTACISER PERINEAL MUSCLE EXERCISER, manufactured by Bivona Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K892888 · Bivona Medical Technologies · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
168d
Days
Class 2
Risk

K892888 is an FDA 510(k) clearance for the EXTACISER PERINEAL MUSCLE EXERCISER. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on October 5, 1989 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K892888

510(k) Number K892888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date October 05, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 131d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 Gastroenterology & Urology devices follow this clearance model.