510(k) · Cleared
ClearedModification of Puresperm
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 Jan 14, 1999 as substantially equivalent to K980814 (Nidacon International AB, 1998) after a 55-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jan 14, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872849 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872849 Sperm-Select Additional IndicationPharmacia, Inc. · 1987
- 2 generations backK971809 IsolateIrvine Scientific Sales Co., Inc. · 1997
- 1 generation backK980814 PurespermNidacon International AB · 1998
- This deviceK984172 Modification of PurespermNidacon International AB · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872849 | Sperm-Select Additional Indication | Pharmacia, Inc. | 1987 | — |
| −2 | K971809 | Isolate | Irvine Scientific Sales Co., Inc. | 1997 | — |
| −1 | K980814 | Puresperm | Nidacon International AB | 1998 | — |
| 0 (this device) | K984172 | Modification of Puresperm | Nidacon International AB | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 |
|---|---|---|---|
| * | K980814 | PurespermSummary page 1…ureSperm® Classification Name/Product Code: Procode: 85 MQL CFR#: 884.6180 Common/Usual Name: Sperm Separation Medium 2. Equivalent legally marketed devices: PureSperm® K980814 3. Indications for Use (intended use) The product is intended to be used for the separation and purification of spermatozoa by d… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
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 spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
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/K984172 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984172: Modification of Puresperm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984172
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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