FDA product code PLB: Multivariate Vital Signs Index
PLB is the FDA product code for multivariate vital signs index. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under PLB, 4 in the last five years, from 7 different applicants. The average 510(k) review took 245 days (median 248); 135 days on average over the last three years.
Definition
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Classification
| Field | Value |
|---|---|
| Device name | Multivariate Vital Signs Index |
| Device class | Class II |
| Regulation | 21 CFR 870.2300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PLB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 262 |
| 2023 | 2 | 282 |
| 2024 | 2 | 135 |
Compare with all 510(k) review times · Search every PLB clearance
Top PLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Etiometry, Inc. | 2 | 2023-01-06 |
| Aitrics Co., Ltd. | 1 | 2024-07-23 |
| Algodx AB | 1 | 2024-07-22 |
| Spass, Inc. | 1 | 2023-06-15 |
| Biofourmis Singapore Pte., Ltd. | 1 | 2019-08-15 |
2 more applicants have PLB clearances. See the full list in Caduvo.
Most recent PLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240756 | Aitrics Co., Ltd. | AITRICS-VC | 2024-07-23 | 125 |
| K240558 | Algodx AB | NAVOYCDS | 2024-07-22 | 145 |
| K230386 | Spass, Inc. | SpassageQ | 2023-06-15 | 121 |
| K213423 | Etiometry, Inc. | T3 Platform software | 2023-01-06 | 443 |
| K183282 | Biofourmis Singapore Pte., Ltd. | Biovitals Analytics Engine | 2019-08-15 | 262 |
Recalls for PLB devices
openFDA lists no recalls for product code PLB.
Frequently asked questions
What is FDA product code PLB?
PLB is the FDA product code for multivariate vital signs index. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel.
What device class is PLB?
Class II, regulation 21 CFR 870.2300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLB?
Across 8 cleared submissions the average was 245 days from receipt to decision (median 248).
Which companies have the most PLB clearances?
Etiometry, Inc. (2); Aitrics Co., Ltd. (1); Algodx AB (1); Spass, Inc. (1); Biofourmis Singapore Pte., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLB
- Run a recall and safety report across every PLB manufacturer
- Watch product code PLB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times