Cleared Traditional

K870356 - TATCH-IT

K870356 is the FDA 510(k) clearance for TATCH-IT by Reunion Medical Co.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K870356 · Reunion Medical Co. · Cardiovascular device
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Jun 1987
Decision
134d
Days
Class 2
Risk

K870356 is an FDA 510(k) clearance for the TATCH-IT. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Reunion Medical Co. (Lenexa, US). The FDA issued a Cleared decision on June 12, 1987 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Reunion Medical Co. devices

Submission Details

510(k) Number K870356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date June 12, 1987
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 73
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