FDA product code KDT: Container, Specimen Mailer And Storage, Sterile
KDT is the FDA product code for container, specimen mailer and storage, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel. FDA has cleared 12 510(k) submissions under KDT, from 10 different applicants. The average 510(k) review took 43 days (median 40). FDA has posted 17 recalls for KDT devices.
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen Mailer And Storage, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KDT clearance
Top KDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preventive Diagnostics Corp. | 2 | 1984-01-13 |
| Sage Products, Inc. | 2 | 1982-02-18 |
| Biosure, Inc. | 1 | 1987-11-25 |
| Xsirius Medical, Inc. | 1 | 1986-09-04 |
| Hospal Medical Corp. | 1 | 1984-02-04 |
5 more applicants have KDT clearances. See the full list in Caduvo.
Most recent KDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873593 | Biosure, Inc. | BIOSURE SPECIMEN COLLECTION CONTAINER | 1987-11-25 | 82 |
| K862665 | Xsirius Medical, Inc. | NOVACYTE-U | 1986-09-04 | 52 |
| K834579 | Hospal Medical Corp. | BIOSPAL 2400S | 1984-02-04 | 37 |
| K834412 | Preventive Diagnostics Corp. | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | 1984-01-13 | 29 |
| K833660 | Preventive Diagnostics Corp. | PRESERV PVA FIXATIVE -MALIN PACK | 1983-11-28 | 41 |
Recalls for KDT devices
17 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-01-09.
Frequently asked questions
What is FDA product code KDT?
KDT is the FDA product code for container, specimen mailer and storage, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel.
What device class is KDT?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDT?
Across 12 cleared submissions the average was 43 days from receipt to decision (median 40).
Which companies have the most KDT clearances?
Preventive Diagnostics Corp. (2); Sage Products, Inc. (2); Biosure, Inc. (1); Xsirius Medical, Inc. (1); Hospal Medical Corp. (1).
Have KDT devices been recalled?
Yes: 17 product recalls across 1 recall events; the most recent began 2011-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KDT
- Run a recall and safety report across every KDT manufacturer
- Watch product code KDT 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 Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times