Cleared Traditional

K875369 - MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT

K875369 is an FDA 510(k) clearance for MODEL ISO-2001 UNIV. PATIENT ISOLATION ..., manufactured by Diamond Medical, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K875369 · Diamond Medical, Inc. · Gastroenterology & Urology device
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Feb 1988
Decision
36d
Days
Class 1
Risk

K875369 is an FDA 510(k) clearance for the MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Diamond Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1400 - 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 Diamond Medical, Inc. devices

FDA 510(k) Submission Details - K875369

510(k) Number K875369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date February 05, 1988
Days to Decision 36 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
95d faster than avg
Panel avg: 131d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

FFT Device Classification - Class 1, General Controls

Product Code FFT Electrode, Ph, Stomach
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1400
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 - FFT Electrode, Ph, Stomach

All 20
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