Cleared Traditional

K143580 - PeriCoach

K143580 is an FDA 510(k) clearance for PeriCoach, manufactured by Analytica, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K143580 · Analytica, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
90d
Days
Class 2
Risk

K143580 is an FDA 510(k) clearance for the PeriCoach. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Analytica, Ltd. (Brisbane, AU). The FDA issued a Cleared decision on March 18, 2015 after a review of 90 days - within the typical 510(k) review window.

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 Analytica, Ltd. devices

FDA 510(k) Submission Details - K143580

510(k) Number K143580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date March 18, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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.

Regulatory Consultant

Brandwood Biomedical
Tracey Bullivant

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 - HIR Perineometer

All 43
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K143580.
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VIBRANCE KEGEL DEVICE (VKD)
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IEVA REHABILITATIVE POSITIONAL DEVICE
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K140780 · Regulatory Insight, Inc. · Sep 2014