FDA product code NDS: Media, Culture, Ex Vivo, Tissue And Cell
NDS is the FDA product code for media, culture, ex vivo, tissue and cell. It is a Class II device, regulated under 21 CFR 876.5885 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under NDS, 3 in the last five years, from 7 different applicants. The average 510(k) review took 212 days (median 172); 272 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 7 recalls for NDS devices.
Classification
| Field | Value |
|---|---|
| Device name | Media, Culture, Ex Vivo, Tissue And Cell |
| Device class | Class II |
| Regulation | 21 CFR 876.5885 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 447 |
| 2023 | 1 | 142 |
| 2024 | 2 | 272 |
Compare with all 510(k) review times · Search every NDS clearance
Top NDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life Technologies Corporation | 2 | 2011-02-18 |
| Yocon Biology Technology Company | 1 | 2024-09-06 |
| Duogenic Stemcells Corporation | 1 | 2024-07-12 |
| Fujifilm Irvine Scientific | 1 | 2023-11-09 |
| Energy Delivery Solutions | 1 | 2021-09-20 |
2 more applicants have NDS clearances. See the full list in Caduvo.
Most recent NDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232543 | Yocon Biology Technology Company | MSC SFM | 2024-09-06 | 381 |
| K240247 | Duogenic Stemcells Corporation | MoFi Cell Culture Basal Medium | 2024-07-12 | 164 |
| K231804 | Fujifilm Irvine Scientific | PRIME-XV FreezIS DMSO-Free MD | 2023-11-09 | 142 |
| K201789 | Energy Delivery Solutions | CT-STOR | 2021-09-20 | 447 |
| K113566 | Life Technologies, Inc. | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | 2012-06-21 | 202 |
Recalls for NDS devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-11.
| Year | Recalls |
|---|---|
| 2018 | 6 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code NDS?
NDS is the FDA product code for media, culture, ex vivo, tissue and cell. It is a Class II device, regulated under 21 CFR 876.5885 and reviewed by the Gastroenterology and Urology panel.
What device class is NDS?
Class II, regulation 21 CFR 876.5885. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDS?
Across 8 cleared submissions the average was 212 days from receipt to decision (median 172).
Which companies have the most NDS clearances?
Life Technologies Corporation (2); Yocon Biology Technology Company (1); Duogenic Stemcells Corporation (1); Fujifilm Irvine Scientific (1); Energy Delivery Solutions (1).
Have NDS devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2019-06-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NDS
- Run a recall and safety report across every NDS manufacturer
- Watch product code NDS 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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