Cleared Traditional

TRAUMA CARE EVALUATION (K843905) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843905 · Quantitative · General Hospital
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Sep 1985
Decision
358d
Days
Class 2
Risk

K843905 is an FDA 510(k) clearance for the TRAUMA CARE EVALUATION. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Quantitative (Mchenry, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.2300 - 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K843905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1984
Decision Date September 26, 1985
Days to Decision 358 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
229d slower than avg
Panel avg: 129d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLB Multivariate Vital Signs Index
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
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 General Hospital devices follow this clearance model.