510(k) · Cleared
Recalled · Class II · 2023Isolate, Isolate Concentrate, Isolate Stock Solution
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 Jul 8, 1999 as substantially equivalent to K971809 (Irvine Scientific Sales Co., Inc., 1997) after an 80-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 8, 1999
- Review
- 80 days
- Class
- Class II
- Product code
- MQL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872849 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872849 Sperm-Select Additional IndicationPharmacia, Inc. · 1987
- 1 generation backK971809 IsolateIrvine Scientific Sales Co., Inc. · 1997
- This deviceK991341 Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK023403 Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002
Most influential descendants
Showing 1 of 1 · See all- K023403Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872849 | Sperm-Select Additional Indication | Pharmacia, Inc. | 1987 | — |
| −1 | K971809 | Isolate | Irvine Scientific Sales Co., Inc. | 1997 | — |
| 0 (this device) | K991341 | Isolate, Isolate Concentrate, Isolate Stock Solution | Irvine Scientific Sales Co., Inc. | 1999 | — |
| +1 | K023403 | Spermgrad, Models 10022/10063 | Vitrolife Sweden AB | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K971809 | IsolateSummary page 3…has been found to perform comparably in sperm survival, forward progression and percent recavery of motile sperm. I1Solate 2-layer kits were cleared for marketing under K971809. ISolate Stock Solution is identical to the “Lower Layer” component of the 2-layer kits. Additional Information: The shelf-ife… | 1997 |
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 |
|---|---|---|---|
| K023403 | Spermgrad, Models 10022/10063 | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2023 | Class II | Z-0998-2024 | Mixed-up of materials/components | The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K023403 (Vitrolife Sweden AB, 2002) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K971809.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two-layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predeminantly motile sperm. It is intended for use as a human sperm separation medium, to concentrate and purify viable sperm, prior to in vitro fertilization, and related assisted reproductive technology, procedures.
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/K991341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991341: Isolate, Isolate Concentrate, Isolate Stock Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991341
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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