510(k) · Cleared
ClearedSingle Step Medium
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 Feb 12, 2008 as substantially equivalent to K034063 (Irvine Scientific Sales Co., Inc., 2004) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 2004. 9 later devices descend from it.
- Decided
- Feb 12, 2008
- Review
- 148 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K034063 (2004). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- This deviceK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- Descendant · cites it directly · 8 of its ownK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK133568 G-TLVitrolife, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK191063 1-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK170681 Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK202862 Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012 · cites it directly8descendants
- K133568G-TLVitrolife, Inc. · 2014 · 2 generations on4descendants
- K1910631-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd. · 2019 · 3 generations on1descendant
- K170681Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017 · 2 generations on1descendant
- K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| 0 (this device) | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| +1 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| +2 | K133568 | G-TL | Vitrolife, Inc. | 2014 | — |
| +3 | K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019 | — |
| +2 | K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | 2017 | — |
| +3 | K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K034063 | Multiblast MediumSummary page 1…Classification Name: Reproductive Media (21 CFR, 884.6180) Predicate Device: Final Rule, 63 FIR 48428, Docket number 97N-0335 MultiBlast Medium (K034063) global®: fertilization, embryo culture and transfer medium (K053552) Description: Single Step Medium is a synthe… | 2004 |
| * | K053552 | Global Fertilization, Embryo Culture and Transfer MediaSummary page 1…ate Device: Final Rule, 63 FIR 48428, Docket number 97N-0335 MultiBlast Medium (K034063) global®: fertilization, embryo culture and transfer medium (K053552) Description: Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, mi… | 2006 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121572 | Continuous Single Culture Complete | 2012 | 8 |
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?
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072609: Single Step Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072609
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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