Cleared Traditional

K924433 - SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1

K924433 is an FDA 510(k) clearance for SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 A..., manufactured by Senior Technologies, Inc.. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K924433 · Senior Technologies, Inc. · General Hospital
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Jun 1993
Decision
296d
Days
Class 1
Risk

K924433 is an FDA 510(k) clearance for the SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Senior Technologies, Inc. (Lincoln, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 296 days - an extended review cycle.

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 Senior Technologies, Inc. devices

FDA 510(k) Submission Details - K924433

510(k) Number K924433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date June 24, 1993
Days to Decision 296 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 129d · This submission: 296d
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.