510(k) · Cleared
ClearedIsocare One Step Sperm Processing Medium Cat# 2207-12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invitrocare, Inc. · MQL Media, Reproductive
Cleared on Dec 26, 2002 as substantially equivalent to K983588 (Irvine Scientific Sales Co., Inc., 1999) after a 90-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Dec 26, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983588 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983588 Sperm Washing Medium, Modified Sperm Washing MediumIrvine Scientific Sales Co., Inc. · 1999
- This deviceK023222 Isocare One Step Sperm Processing Medium Cat# 2207-12Invitrocare, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983588 | Sperm Washing Medium, Modified Sperm Washing Medium | Irvine Scientific Sales Co., Inc. | 1999 | — |
| 0 (this device) | K023222 | Isocare One Step Sperm Processing Medium Cat# 2207-12 | Invitrocare, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K983588 | Sperm Washing Medium, Modified Sperm Washing MediumSummary page 1…ve Media (21CFR, 886.6 180) Predicate Device: Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 and 5 1O(k) Reference Number K983588 Description: ISOCARE ONE-STEP Sperm Processing Medium is a synthetic, defined culture medium compo… | 1999 |
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?
- Its one ancestor has no 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?
ISOCAFE ONE-STEP Sperm Processing Medium is intended for use in assisted reproductive technology procedures that involve the isolation, processing and transfer of sperm. Specifically, ISOCARE ONE-STEP Sperm Processing Medium is intended for use as a sperm isolation and processing medium in the isolation and processing of sperm during intrauterine and reproductive technology procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023222: Isocare One Step Sperm Processing Medium Cat# 2207-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023222
Report an extraction error
Are you the manufacturer?
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