KDT
12 FDA 510(k) clearances · Product code
41 daysmedian time to decision
59 days90th percentile
12clearances measured
FDA profile
- Official device name
- Container, Specimen Mailer And Storage, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3250
- Medical specialty
- Pathology
- Adverse events (MAUDE)
- 2018: 70 · 2019: 51 · 2020: 21 · 2021: 27 · 2022: 39 · 2023: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIOSURE SPECIMEN COLLECTION CONTAINER (K873593) | Biosure, Inc. | 1987-11-25 |
| NOVACYTE-U (K862665) | Xsirius Medical, Inc. | 1986-09-04 |
| BIOSPAL 2400S (K834579) | Hospal Medical Corp. | 1984-02-04 |
| PRESERV PVA FIXATIVE 15ML-FORMALIN PK (K834412) | Preventive Diagnostics Corp. | 1984-01-13 |
| PRESERV PVA FIXATIVE -MALIN PACK (K833660) | Preventive Diagnostics Corp. | 1983-11-28 |
| PROVIAL II #006-010-0201 (K823773) | Dynatech Corp. | 1983-01-21 |
| STOOL-COLLECTION/PRESERVATION KIT (K822870) | American Scientific Products | 1982-11-01 |
| PREGNOPOST (K821621) | M.M. Wolfred, Ph.D. | 1982-07-21 |
| PREFILLED SPECIMEN CONTAINER (K820246) | Sage Products, Inc. | 1982-02-18 |
| FIX-RIGHT 90ML & 180 ML PREFILLED CONT (K811793) | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| URINARY CATHETER SAMPLING KIT (K800946) | Sage Products, Inc. | 1980-06-20 |
| PINLOCK CONTAINER (K770071) | Perkins Mfg. Co. | 1977-02-24 |
Track KDT automatically
Every clearance here is in the API, with alerts when new ones post.