510(k) · Cleared
ClearedFollicle Aspiration Set, Reduced Single Lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife Sweden AB · MQE Needle, Assisted Reproduction
Cleared on Feb 6, 2009 as substantially equivalent to K991273 (Swemed Lab International AB, 1999) after a 142-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991273 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991273 Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer…Swemed Lab International AB · 1999
- This deviceK082727 Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2009
- Descendant · cites it directly · 1 of its ownK112462 Kitazato Opu NeedleKitazato Medical Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK172050 Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2017
- Descendant · 2 generations on · 0 of its ownK162881 Kitazato OPU NeedlesKitazato Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle | Swemed Lab International AB | 1999 | — |
| 0 (this device) | K082727 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2009 | — |
| +1 | K112462 | Kitazato Opu Needle | Kitazato Medical Co., Ltd. | 2012 | — |
| +1 | K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2017 | — |
| +2 | K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 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 MQE? 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 MQE device
- #1 K240523 VitaVitro® Single Lumen Oocyte Retrieval…score 8.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer NeedleSummary page 1…Set Classification Name: Assisted Reproduction Needles (21 C.F.R1§ 884.6100) Predicate Device: Follicle Aspiration Set (K991273) Description of the Device: The Follicle Aspiration Set, Reduced Single Lumen device is a modification of the cur… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MQE
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQE
197in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQE
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQE
37in 2025
MAUDE reports naming product code MQE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 4 | 234 | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 197 | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 37 |
| 2024 | 2 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 37 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Follicle Aspiration Set, Reduced Single Lumen is indicated for flushing and/or aspiration of oocytes from ovarian follicles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082727: Follicle Aspiration Set, Reduced Single Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082727
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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