FDA product code JCA: Device, Bleeding Time
JCA is the FDA product code for device, bleeding time. It is a Class II device, regulated under 21 CFR 864.6100 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under JCA, from 6 different applicants. The average 510(k) review took 64 days (median 72). FDA has posted 1 recall for JCA devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Bleeding Time |
| Device class | Class II |
| Regulation | 21 CFR 864.6100 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JCA clearance
Top JCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Technidyne Corp. | 2 | 1991-07-17 |
| Organon Teknika Corp. | 1 | 1991-08-09 |
| Helena Laboratories | 1 | 1987-06-10 |
| American Dade | 1 | 1983-03-17 |
| Ulster Scientific, Inc. | 1 | 1980-10-10 |
1 more applicants have JCA clearances. See the full list in Caduvo.
Most recent JCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911745 | Organon Teknika Corp. | SIMPLATE PEDIATRIC | 1991-08-09 | 113 |
| K911996 | International Technidyne Corp. | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | 1991-07-17 | 86 |
| K871318 | Helena Laboratories | Q.I.C. BLEEDING TIME DEVICE | 1987-06-10 | 68 |
| K850542 | International Technidyne Corp. | SURGICUTT - BLEEDING TIME DEVICE | 1985-03-01 | 18 |
| K830645 | American Dade | BLEEDING TIME DEVICE DISPOSABLE | 1983-03-17 | 16 |
Recalls for JCA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-22.
Frequently asked questions
What is FDA product code JCA?
JCA is the FDA product code for device, bleeding time. It is a Class II device, regulated under 21 CFR 864.6100 and reviewed by the Hematology panel.
What device class is JCA?
Class II, regulation 21 CFR 864.6100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCA?
Across 7 cleared submissions the average was 64 days from receipt to decision (median 72).
Which companies have the most JCA clearances?
International Technidyne Corp. (2); Organon Teknika Corp. (1); Helena Laboratories (1); American Dade (1); Ulster Scientific, Inc. (1).
Have JCA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-08-22.
Next steps
- Run an FDA pathway report with predicate devices for product code JCA
- Run a recall and safety report across every JCA manufacturer
- Watch product code JCA 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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