Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NDS — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
164 daysmedian FDA review time
447 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 | 381 | 0 |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 | 164 | 0 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 | 142 | 0 |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 | 447 | 0 |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 | 202 | 1 |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | 2011-02-18 | 101 | 0 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, | Life Technologies Corporation | 2010-05-20 | 77 | 0 |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 | 179 | 1 |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | 2001-02-16 | 59 | 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