510(k) · Cleared
Recalled · Class II · 2024ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origio A/S · MQL Media, Reproductive
Cleared on Jul 22, 2016 as substantially equivalent to K003404 (Medicult A/S, 2001) and 1 other predicate after a 253-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 22, 2016
- Review
- 253 days
- Class
- Class II
- Product code
- MQL
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991332 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K241833V-GRADVitromed GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991332 | Medi-Cult Sperm Preparation - Medium; | Medicult A/S | 2000 | — |
| 0 (this device) | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm… | Origio A/S | 2016 | — |
| +1 | K241833 | V-GRAD | Vitromed GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K003404 | Suprasperm SystemSummary page 4…and Sperm Wash Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate Devices: SupraSperm™ System (K003404) from ORIGIO is the predicate device for ORIGIO® Gradient™ devices Sperm Preparation Medium (K991332) from ORIGIO is the predica… | 2001 |
| * | K991332 | Medi-Cult Sperm Preparation - Medium;Summary page 4…Code MQL) Predicate Devices: SupraSperm™ System (K003404) from ORIGIO is the predicate device for ORIGIO® Gradient™ devices Sperm Preparation Medium (K991332) from ORIGIO is the predicate device for ORIGIO® Sperm Wash. Device Description: ORIGIO® Sperm Wash and ORIGIO® Gradient™ devic… | 2000 |
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 |
|---|---|---|---|
| K241833 | V-GRAD | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2024 | Class II | Z-3297-2024 | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| Feb 16, 2024 | Class II | Z-3296-2024 | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| Feb 16, 2024 | Class II | Z-3298-2024 | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K241833 (Vitromed GmbH, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method,
dilution of ORIGIO gradients, and holding sperm for IUI procedure
ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm
from the ejaculate by the density gradient method.
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/K153267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153267
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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