510(k) · Cleared

Cleared

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

K173686510(k) TraditionalCleared Apr 11, 2018131-day reviewClass II21 CFR 884.6110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Incorporated · MQF Catheter, Assisted Reproduction

Cleared on Apr 11, 2018 as substantially equivalent to K983594 (Cook Ob/Gyn, 1998) after a 131-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Apr 11, 2018
Review: 131 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.

By dateBy generation

Root · 1 generation backK983594 Embryo Transfer Catheters/SetsCook Ob/Gyn · 1998 · Recalled
This deviceK173686 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF®…Cook Incorporated · 2018
Descendant · cites it directly · 0 of its ownK192540 Kitazato ET CathetersKitazato Corporation · 2020

Most influential descendants

Showing 1 of 1 · See all

K192540Kitazato ET CathetersKitazato Corporation · 2020 · 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)	K173686	Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter	Cook Incorporated	2018	—
+1	K192540	Kitazato ET Catheters	Kitazato Corporation	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K173686, 1998–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K983594	Embryo Transfer Catheters/Sets Summary page 4 …ification Regulation: MQF (Catheter, Assisted Reproduction) Regulatory Class 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: The…	Cook Ob/Gyn	1998	3

Also cleared against K983594: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K192540	Kitazato ET Catheters	Kitazato Corporation	2020	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?

Its one ancestor has a recall.
Of its descendants, K192540 (Kitazato Corporation, 2020) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K983594.

How does its category compare?

All MQF devices

MQF 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

2007high 6 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQF

196in 2018

2007high 230 (2017) · low 196 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQF

2in 2019

2007high 6 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQF

13in 2025

2007high 27 (2018) · low 0 (2008)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?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter:

Used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173686: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173686

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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