510(k) · Cleared
ClearedContinuous Single Culture -NX (CSCM-NX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · MQL Media, Reproductive
Cleared on Jun 8, 2017 as substantially equivalent to K121572 (Irvine Scientific Sales Co., Inc., 2012) after a 94-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Jun 8, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K034063 (2004). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- 2 generations backK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- 1 generation backK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- This deviceK170681 Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017
- Descendant · cites it directly · 0 of its ownK193522 iMedium Single Step; iMedium Single Step with HSA; iMedium Single…Kitazato Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAKitazato Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −2 | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| −1 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| 0 (this device) | K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | 2017 | — |
| +1 | K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Kitazato Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 MQL? 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 MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K121572 | Continuous Single Culture CompleteSummary page 4…6180) Product code: MQL (Media, Reproductive) Regulatory Class: II IV. Predicate Device: Continuous Single Culture Complete (K121572), manufactured by Irvine Scientific Sales Co., Inc. This predic… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | 2020 | 0 |
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 13 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K193522 (Kitazato Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121572.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.
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/K170681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170681: Continuous Single Culture -NX (CSCM-NX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170681
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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