510(k) · Cleared
ClearedKitazato OPU Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQE Needle, Assisted Reproduction
Cleared on Jul 11, 2017 as substantially equivalent to K112462 (Kitazato Medical Co., Ltd., 2012) after a 270-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 11, 2017
- Review
- 270 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991273 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK991273 Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer…Swemed Lab International AB · 1999
- 2 generations backK082727 Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2009
- 1 generation backK112462 Kitazato Opu NeedleKitazato Medical Co., Ltd. · 2012
- This deviceK162881 Kitazato OPU NeedlesKitazato Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991273 | Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle | Swemed Lab International AB | 1999 | — |
| −2 | K082727 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2009 | — |
| −1 | K112462 | Kitazato Opu Needle | Kitazato Medical Co., Ltd. | 2012 | — |
| 0 (this device) | K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K112462 | Kitazato Opu Needle Our reading of the summary gave K112492, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kitazato OPU Needle with Connection Tube, Type2 and Kitazato OPU…”. | 2012 |
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 18 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Type2)
• Kitazato OPU Reduced Needle (model number Type3)
• Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162881: Kitazato OPU Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162881
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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