510(k) · Cleared
ClearedGuardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MQF Catheter, Assisted Reproduction
Cleared on Jan 10, 2018 as substantially equivalent to K983594 (Cook Ob/Gyn, 1998) after a 188-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jan 10, 2018
- Review
- 188 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983594 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983594 Embryo Transfer Catheters/SetsCook Ob/Gyn · 1998 · Recalled
- This deviceK172051 Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets…Cook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK220010 Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983594 | Embryo Transfer Catheters/Sets | Cook Ob/Gyn | 1998 | 3 |
| 0 (this device) | K172051 | Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans… | Cook Incorporated | 2018 | — |
| +1 | K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | Shanghai Horizon Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 MQF? 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 MQF device
- #1 K253354 Minvitro Embryo Transfer Catheters (ETCA23175…score 11.4 · 3 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 |
|---|---|---|---|
| * | K983594 | Embryo Transfer Catheters/SetsSummary page 6…MQF (Catheter, Assisted Reproduction) Regulatory Class/Classification Panel: II Predicate Device: Embryo Transfer Catheter/Sets (K983594) manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls. Device Description: This… | 1998 |
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 |
|---|---|---|---|
| K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | 2022 | 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?
How does its category compare?
All MQF devicesMQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MQF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQF
196in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQF
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQF
13in 2025
MAUDE reports naming product code MQF, 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 | — | 6 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 6 | 230 | 0 | 10 |
| 2018 | 5 | 196 | 0 | 27 |
| 2019 | 2 | — | 2 | 16 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 11 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 1 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Used to place in vitro fertilized (IVF) embryos into the uterine cavity. This device is to be used in combination with a cleared, dimensionally compatible Embryo Transfer Guide Catheter for gaining access to the uterine cavity.
Used to supplement and assist uterine access of a cleared, dimensionally compatible Embryo Transfer Catheter for placement of in vitro fertilized (IVF) embryos into the uterine cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172051: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172051
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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