Cleared Traditional

RSVP RF-2000 (K905586) - FDA 510(k) Clearance

Class I General Hospital device.

K905586 · Tactilitics, Inc. · General Hospital
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Apr 1991
Decision
116d
Days
Class 1
Risk

K905586 is an FDA 510(k) clearance for the RSVP RF-2000. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Tactilitics, Inc. (Boulder, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tactilitics, Inc. devices

Submission Details

510(k) Number K905586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date April 01, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
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.