510(k) · Cleared
ClearedSwemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swemed Lab International AB · MQE Needle, Assisted Reproduction
Cleared on Aug 18, 1999 after a 127-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 18, 1999
- Review
- 127 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK991273 Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer…Swemed Lab International AB · 1999
- Descendant · cites it directly · 3 of its ownK082727 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 · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK161970 Follicle Aspiration SetVitrolife Sweden AB · 2017
Most influential descendants
Showing 5 of 5 · See all- K082727Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2009 · cites it directly3descendants
- K112462Kitazato Opu NeedleKitazato Medical Co., Ltd. · 2012 · cites it directly1descendant
- K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2017 · 2 generations on0descendants
- K162881Kitazato OPU NeedlesKitazato Corporation · 2017 · 2 generations on0descendants
- K161970Follicle Aspiration SetVitrolife Sweden AB · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle | Swemed Lab International AB | 1999 | — |
| +1 | K082727 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2009 | — |
| +1 | K112462 | Kitazato Opu Needle | Kitazato Medical Co., Ltd. | 2012 | — |
| +2 | K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2017 | — |
| +2 | K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017 | — |
| +1 | K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 3 | 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 8.4 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Cook OB/GYN Ovum Pick-Up Aspiration Needles, Single Lumen and Double Lumen Named without a submission number | |
| * | — | Swemed Needle For Amniocentesis And Cyst Puncture Named without a submission number |
What descends from it? (5)
3 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?
- Of its descendants, K082727 (Vitrolife Sweden AB, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Swemed Follicle Aspiration Set, Double Lumen; Swemed Follicle Aspiration Set, Single Lumen; and Swemed Follicle Aspiration Luer Needle and intended to obtain gametes from the body and are specifically indicated for flushing and/or aspiration of oocytes from ovarian follicles.
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/K991273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991273: Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991273
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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