510(k) · Cleared
ClearedKitazato Opu Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Medical Co., Ltd. · MQE Needle, Assisted Reproduction
Cleared on Nov 26, 2012 as substantially equivalent to K082727 (Vitrolife Sweden AB, 2009) and 1 other predicate after a 458-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Nov 26, 2012
- Review
- 458 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991273 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991273 Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer…Swemed Lab International AB · 1999
- 1 generation backK082727 Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2009
- This deviceK112462 Kitazato Opu NeedleKitazato Medical Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK162881 Kitazato OPU NeedlesKitazato Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K162881Kitazato OPU NeedlesKitazato Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K112462 | Kitazato Opu Needle | Kitazato Medical Co., Ltd. | 2012 | — |
| +1 | K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K082727 | Follicle Aspiration Set, Reduced Single LumenSummary page 2…Code: MQE Device Class: 11 5. Predicate Devices Vitrolife Sweden AB - Follicle Aspiration Set, Reduced Single Lumen (K082727) Swemed Lab International AB - Swemned Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (K991273) 6. D… | 2009 |
| * | K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer NeedleSummary page 2…Follicle Aspiration Set, Reduced Single Lumen (K082727) Swemed Lab International AB - Swemned Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (K991273) 6. Device Description The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ov… | 1999 |
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 |
|---|---|---|---|
| K162881 | Kitazato OPU Needles | 2017 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162881 (Kitazato Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082727.
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Kitazato OPU Needles consisting of:
* Kitazato OPU Needle with Connection Tube, model number Type 2
* Kitazato OPU Reduced Needle, model number Type 3
are intended to obtain oocytes from ovarian follicles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112462: Kitazato Opu Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112462
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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