Cleared Traditional

K905586 - RSVP RF-2000

K905586 is an FDA 510(k) clearance for RSVP RF-2000, manufactured by Tactilitics, Inc.. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K905586

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.

KMI Device Classification - Class 1, General Controls

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.