510(k) · Cleared
ClearedPuresperm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidacon International AB · MQL Media, Reproductive
Cleared on Jun 23, 1998 as substantially equivalent to K971809 (Irvine Scientific Sales Co., Inc., 1997) and 2 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Jun 23, 1998
- Review
- 112 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
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 deviceK980814 PurespermNidacon International AB · 1998
- Descendant · cites it directly · 0 of its ownK984172 Modification of PurespermNidacon International AB · 1999
Most influential descendants
Showing 1 of 1 · See all- K984172Modification of PurespermNidacon International AB · 1999 · 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) | K980814 | Puresperm | Nidacon International AB | 1998 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 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? (3)
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 1…® Classification Name/Product Code: 85 MQL(Cervical Cap per 21 CFR 884.5250) Common/Usual Name: Sperm Separation Medium 2. Equivalent legally marketed devices: ISolate: K971809, Modified Ham's F-10: K894432, Sperm Select: K872849. 3. Indications for Use (intended use) The product is intended to be used f… | 1997 |
| * | K894432 | Modified Ham's F-10 W/AlbuminSummary page 1…Code: 85 MQL(Cervical Cap per 21 CFR 884.5250) Common/Usual Name: Sperm Separation Medium 2. Equivalent legally marketed devices: ISolate: K971809, Modified Ham's F-10: K894432, Sperm Select: K872849. 3. Indications for Use (intended use) The product is intended to be used for the separation and purifica… | 1989 |
| * | K872849 | Sperm-Select Additional IndicationSummary page 1…ap per 21 CFR 884.5250) Common/Usual Name: Sperm Separation Medium 2. Equivalent legally marketed devices: ISolate: K971809, Modified Ham's F-10: K894432, Sperm Select: K872849. 3. Indications for Use (intended use) The product is intended to be used for the separation and purification of human sperm by… | 1987 |
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 |
|---|---|---|---|
| K984172 | Modification of Puresperm | 1999 | 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 11 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K984172 (Nidacon International AB, 1999) 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?
The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (TUI).
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/K980814 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980814: Puresperm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980814
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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