FDA product code KSD: Device, Heat-Sealing
KSD is the FDA product code for device, heat-sealing. It is a Class I device, regulated under 21 CFR 864.9750 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSD. The average 510(k) review took 64 days (median 64). FDA has posted 1 recall for KSD devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Heat-Sealing |
| Device class | Class I |
| Regulation | 21 CFR 864.9750 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Top KSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North American Biologicals, Inc. | 1 | 1982-04-09 |
Most recent KSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820301 | North American Biologicals, Inc. | PLASMA POOLER HEAT SEALER | 1982-04-09 | 64 |
Recalls for KSD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-01-31.
Frequently asked questions
What is FDA product code KSD?
KSD is the FDA product code for device, heat-sealing. It is a Class I device, regulated under 21 CFR 864.9750 and reviewed by the Hematology panel.
What device class is KSD?
Class I, regulation 21 CFR 864.9750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSD?
Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most KSD clearances?
North American Biologicals, Inc. (1).
Have KSD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code KSD
- Run a recall and safety report across every KSD manufacturer
- Watch product code KSD 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.