510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K183282Substantially Equivalent

Biovitals Analytics Engine

Biofourmis Singapore Pte., Ltd., Singapore, SG / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183282 is the FDA 510(k) clearance record for Biovitals Analytics Engine, a class II device, cleared for Biofourmis Singapore Pte., Ltd. 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 4 510(k) clearances for Biofourmis Singapore Pte., Ltd., from to . As of , FDA records show no recalls naming K183282.

Clearance record

Decision date
Received
(262 days to decision)
Product code
PLB Multivariate Vital Signs Index
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Biofourmis Singapore Pte., Ltd. Vision Exchange, #07-15, 2 Venture Dr., Singapore, SG
510(k) summary
Summary PDF
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