510(k) · Cleared
ClearedIsolate
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 3, 1997 as substantially equivalent to K872849 (Pharmacia, Inc., 1987) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872849 (1987). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK872849 Sperm-Select Additional IndicationPharmacia, Inc. · 1987
- This deviceK971809 IsolateIrvine Scientific Sales Co., Inc. · 1997
- Descendant · cites it directly · 1 of its ownK991341 Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. · 1999 · Recalled
- Descendant · cites it directly · 1 of its ownK980814 PurespermNidacon International AB · 1998
- Descendant · 2 generations on · 0 of its ownK023403 Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002
- Descendant · 2 generations on · 0 of its ownK984172 Modification of PurespermNidacon International AB · 1999
Most influential descendants
Showing 4 of 4 · See all- K991341Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. · 1999 · cites it directly1descendant
- K980814PurespermNidacon International AB · 1998 · cites it directly1descendant
- K023403Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002 · 2 generations on0descendants
- K984172Modification of PurespermNidacon International AB · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872849 | Sperm-Select Additional Indication | Pharmacia, Inc. | 1987 | — |
| 0 (this device) | K971809 | Isolate | Irvine Scientific Sales Co., Inc. | 1997 | — |
| +1 | K991341 | Isolate, Isolate Concentrate, Isolate Stock Solution | Irvine Scientific Sales Co., Inc. | 1999 | 1 |
| +1 | K980814 | Puresperm | Nidacon International AB | 1998 | — |
| +2 | K023403 | Spermgrad, Models 10022/10063 | Vitrolife Sweden AB | 2002 | — |
| +2 | K984172 | Modification of Puresperm | Nidacon International AB | 1999 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K872849 | Sperm-Select Additional IndicationSummary page 1…entification: » Trade Name: ISolate « Common Name: Sperm Separation Medium « Classification Name: Cervical Cap (per 21CFR 884.5250) Predicate Devices: » Sperm Select (K872849) + Modified Ham's F-10 (K894432) Description: The product is a colloidal suspension of silica particles which have been covalent… | 1987 |
| * | K894432 | Modified Ham's F-10 W/AlbuminSummary page 1…ate « Common Name: Sperm Separation Medium « Classification Name: Cervical Cap (per 21CFR 884.5250) Predicate Devices: » Sperm Select (K872849) + Modified Ham's F-10 (K894432) Description: The product is a colloidal suspension of silica particles which have been covalently modified with hydrophilic sil… | 1989 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
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 product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).
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/K971809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971809: Isolate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971809
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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