PLB · Class II · 21 CFR 870.2300

FDA Product Code PLB: Multivariate Vital Signs Index

Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.

Leading manufacturers include Biofourmis Singapore Pte., Ltd., Etiometry, Inc. and Spass, Inc..

8
Total
8
Cleared
245d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Multivariate Vital Signs Index Devices (Product Code PLB)

8 devices
1–8 of 8
Cleared Jul 23, 2024
AITRICS-VC
K240756
Aitrics Co., Ltd.
Cardiovascular · 125d
Cleared Jul 22, 2024
NAVOYCDS
K240558
Algodx AB
Cardiovascular · 145d
Cleared Jun 15, 2023
SpassageQ
K230386
Spass, Inc.
Cardiovascular · 121d
Cleared Jan 06, 2023
T3 Platform software
K213423
Etiometry, Inc.
Cardiovascular · 443d
Cleared Aug 15, 2019
Biovitals Analytics Engine
K183282
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 262d

About Product Code PLB - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code PLB since 1985, with 8 receiving FDA clearance (average review time: 245 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.