FDA product code JBP: Activated Whole Blood Clotting Time
JBP is the FDA product code for activated whole blood clotting time. It is a Class II device, regulated under 21 CFR 864.7140 and reviewed by the Hematology panel. FDA has cleared 24 510(k) submissions under JBP, 1 in the last five years, from 15 different applicants. The average 510(k) review took 111 days (median 102). FDA has posted 10 recalls for JBP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Activated Whole Blood Clotting Time |
| Device class | Class II |
| Regulation | 21 CFR 864.7140 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every JBP clearance
Top JBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sienco, Inc. | 4 | 2023-01-04 |
| International Technidyne Corp. | 4 | 1996-08-12 |
| Helena Laboratories | 2 | 2002-05-23 |
| Array Medical, Inc. | 2 | 1998-12-11 |
| Hemotec, Inc. | 2 | 1990-07-03 |
10 more applicants have JBP clearances. See the full list in Caduvo.
Most recent JBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223635 | Sienco, Inc. | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | 2023-01-04 | 30 |
| K062604 | Haemoscope Corp. | RAPIDTEG TEG-ACT TEST | 2007-01-31 | 152 |
| K032952 | Sienco, Inc. | AIACT KIT | 2003-12-12 | 81 |
| K023582 | I-Stat Corporation | I-STAT KAOLIN ACT TEST | 2003-09-08 | 319 |
| K020914 | Helena Laboratories | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | 2002-05-23 | 63 |
Recalls for JBP devices
10 product recalls in 8 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-05.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code JBP?
JBP is the FDA product code for activated whole blood clotting time. It is a Class II device, regulated under 21 CFR 864.7140 and reviewed by the Hematology panel.
What device class is JBP?
Class II, regulation 21 CFR 864.7140. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBP?
Across 24 cleared submissions the average was 111 days from receipt to decision (median 102).
Which companies have the most JBP clearances?
Sienco, Inc. (4); International Technidyne Corp. (4); Helena Laboratories (2); Array Medical, Inc. (2); Hemotec, Inc. (2).
Have JBP devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2025-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JBP
- Run a recall and safety report across every JBP manufacturer
- Watch product code JBP 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.
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