510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843905Substantially Equivalent

Trauma Care Evaluation

Quantitative, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843905 is the FDA 510(k) clearance record for TRAUMA CARE EVALUATION, a class II device, cleared for Quantitative on under FDA product code PLB (Multivariate Vital Signs Index). FDA's definition for product code PLB reads: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs". FDA records list one 510(k) clearance for Quantitative. As of , FDA records show no recalls naming K843905.

Clearance record

Decision date
Received
(358 days to decision)
Product code
PLB Multivariate Vital Signs Index
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Quantitative 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code PLB

Trailing 12 months

FDA records hold no clearances under product code PLB in the trailing twelve months.

FDA records show no clearances under product code PLB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260