510(k) · Cleared
ClearedPRIME-XV FreezIS DMSO-Free MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Irvine Scientific · NDS Media, Culture, Ex Vivo, Tissue And Cell
Cleared on Nov 9, 2023 as substantially equivalent to K022086 (Invitrogen Corporation, 2002) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 9, 2023
- Review
- 142 days
- Class
- Class II
- Product code
- NDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN000008 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- 2 generations backK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · Recalled
- 1 generation backK201789 CT-StorEnergy Delivery Solutions · 2021
- This deviceK231804 PRIME-XV FreezIS DMSO-Free MDFujifilm Irvine Scientific · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| −2 | K022086 | Aim-V (R) Medium, Model 087-0112 | Invitrogen Corporation | 2002 | 1 |
| −1 | K201789 | CT-Stor | Energy Delivery Solutions | 2021 | — |
| 0 (this device) | K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDS device
- #1 K232543 MSC SFMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022086 | Aim-V (R) Medium, Model 087-0112Summary page 5…885 Panel: Gastroenterology/Urology Legally Marketed Devices for AIM-V® Medium, Invitrogen Corporation, 510(k) K022086 Invitrogen Corporation. Substantial Equivalence Comparison: CT-STOR medium for ex vivo cell preservation, Ener… | 2002 |
| * | K201789 | CT-StorSummary page 5…parison: CT-STOR medium for ex vivo cell preservation, Energy Delivery Solutions, 510(k) K201789 Energy Delivery Solutions.… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K022086.
How does its category compare?
All NDS devicesNDS Media, Culture, Ex Vivo, Tissue And Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NDS
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NDS
Too few NDS 510(k)s in any year since 2007 to give a median.
Recalls per year · NDS
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDS
No MAUDE report names NDS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PRIME-XV FreezlS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231804: PRIME-XV FreezIS DMSO-Free MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231804
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026