510(k) · Cleared
ClearedGM501 SpermAir and GM501 SpermActive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne Incorporated · MQL Media, Reproductive
Cleared on Apr 23, 2020 as substantially equivalent to K190199 (Kitazato Corporation, 2019) after a 212-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 23, 2020
- Review
- 212 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002383 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002383 Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm…Cook Ob/Gyn · 2000
- 2 generations backK152782 Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf…William A. Cook Australia Pty., Ltd. · 2015
- 1 generation backK190199 SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 2019
- This deviceK192644 GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit | Cook Ob/Gyn | 2000 | — |
| −2 | K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient | William A. Cook Australia Pty., Ltd. | 2015 | — |
| −1 | K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | 2019 | — |
| 0 (this device) | K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | 2020 | — |
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 |
|---|---|---|---|
| * | K190199 | SepaSperm Washing Solution, SepaSperm Solution Cleared while this submission was under review Summary page 4…a and Supplements Regulation Number: 21 CFR 884.6180 Product Code: MQL (Media, Reproductive) Regulatory Class: Class II Predicate Device: K190199 – Kitazato Corporation - SepaSperm® Washing Solution. The predicate device has not been subject to a des… | 2019 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K190199.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures.
GM501 SpermAir is not intended for use in intrauterine insemination procedures.
GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reproduction procedures.
GM501 SpermActive is not intended for use in intrauterine insemination procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192644: GM501 SpermAir and GM501 SpermActive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192644
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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