Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QBD — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
286 daysmedian FDA review time
746 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC | 2025-05-27 | 251 | 0 |
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | 2024-10-11 | 203 | 0 |
| K222771 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 2024-06-26 | 651 | 0 |
| K233324 | Molecular Transport Media - MTM | Alb Luz | 2024-06-17 | 262 | 0 |
| K221547 | InActiv Blue | Fertipro NV | 2024-06-11 | 746 | 0 |
| K212878 | Sample preservation solution | Zhejiang Gene Science Co., Ltd. | 2024-04-08 | 942 | 0 |
| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research | 2023-09-28 | 171 | 0 |
| K221664 | CLEARinse CTS Specimen Collection and Transport System | Aardvark Medical, Inc. | 2023-07-03 | 390 | 0 |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction L | Mawi Dna Technologies | 2023-04-03 | 286 | 0 |
| K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023-02-17 | 88 | 0 |
| K220059 | Biosci™ Inactivated Transport Medium, Biosci™ ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-01-19 | 374 | 0 |
| K211675 | Dasky Disposable Sampling Tube (Model name: VSM02) | Ningbo Dasky Life Science Co., Ltd. | 2022-08-08 | 433 | 0 |
| K212113 | MagXtract Collection Tube | Magbio Genomics, Inc. | 2022-07-28 | 386 | 0 |
| K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM | Wuxi Nest Biotechnology Co., Ltd. | 2021-09-20 | 220 | 0 |
| K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020-12-14 | 94 | 0 |
| K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020-09-17 | 73 | 0 |
| DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018-03-19 | 299 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda