FDA product code KDW: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
KDW is the FDA product code for container, specimen mailer and storage, temperature controlled, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under KDW, from 4 different applicants. The average 510(k) review took 146 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen Mailer And Storage, Temperature Controlled, 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 KDW clearance
Top KDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Substance Abuse Specialties, Inc. | 1 | 1997-04-17 |
| Harry A. Schlakman | 1 | 1995-05-05 |
| Gbf Medical Group | 1 | 1994-05-10 |
| Doxtech, Inc. | 1 | 1991-10-18 |
Most recent KDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970580 | Substance Abuse Specialties, Inc. | SASI-DC1TS | 1997-04-17 | 62 |
| K951122 | Harry A. Schlakman | CAPITOL URINE DRUG SCREEN COLLECTION KIT | 1995-05-05 | 67 |
| K931474 | Gbf Medical Group | DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS | 1994-05-10 | 412 |
| K913967 | Doxtech, Inc. | DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM | 1991-10-18 | 43 |
Recalls for KDW devices
openFDA lists no recalls for product code KDW.
Frequently asked questions
What is FDA product code KDW?
KDW is the FDA product code for container, specimen mailer and storage, temperature controlled, sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel.
What device class is KDW?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDW?
Across 4 cleared submissions the average was 146 days from receipt to decision (median 64).
Which companies have the most KDW clearances?
Substance Abuse Specialties, Inc. (1); Harry A. Schlakman (1); Gbf Medical Group (1); Doxtech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KDW
- Run a recall and safety report across every KDW manufacturer
- Watch product code KDW 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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