510(k) · Cleared

Cleared

Graduated Adapter with Clave

K080007510(k) TraditionalCleared May 13, 2008132-day reviewClass II21 CFR 876.5130

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

Icu Medical, Inc. · EZD Catheter, Straight

Cleared on May 13, 2008 as substantially equivalent to K915571 (Icu Medical, Inc., 1992) and 5 other predicates after a 132-day review. Its family tree reaches back 1 generation to 1992. 1 of the 7 devices in its family, counting itself, has a Class I recall.

Decided: May 13, 2008
Review: 132 days
Class: Class II
Product code: EZD
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K915571 (1992). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
This deviceK080007 Graduated Adapter with ClaveIcu Medical, Inc. · 2008

Class I recalls in this family

K964435 Primary IV Setdirect predicate · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915571	Clave Connector	Icu Medical, Inc.	1992	3
0 (this device)	K080007	Graduated Adapter with Clave	Icu Medical, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	2	1
2004	2	0

FIG. 1 — Lineage of K080007, 1992–2008Source: 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.

1 device in this family has a Class I recall. 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 EZD device

#1 K241210 Luja Coudescore 16.2 · 7 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? (6)

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
*	K915571	Clave Connector Summary page 1 …graduated adapter Classification Name: Accessory to Urological Catheter 21 CFR 876.5130 (EZD) Legally Marketed Predicate Devices for Substantial Equivalence: K915571 – Clave Connector – ICU Medical Inc. K970855 – Clave Connector – ICU Medical, Inc. *K941190 – Clave Needless Connector – ICU Med…	Icu Medical, Inc.	1992	3
*	K970855	Clave Connector Summary page 1 …Accessory to Urological Catheter 21 CFR 876.5130 (EZD) Legally Marketed Predicate Devices for Substantial Equivalence: K915571 – Clave Connector – ICU Medical Inc. K970855 – Clave Connector – ICU Medical, Inc. K941190 – Clave Needless Connector – ICU Medical, Inc. K964435 – Primary IV Set – ICU Med…	Icu Medical, Inc.	1997	52
*	K941190	Clave Needle-Less Connector Open Extension Set Summary page 1 …30 (EZD) Legally Marketed Predicate Devices for Substantial Equivalence: K915571 – Clave Connector – ICU Medical Inc. K970855 – Clave Connector – ICU Medical, Inc. K941190 – Clave Needless Connector – ICU Medical, Inc. K964435 – Primary IV Set – ICU Medical, Inc. *K042182 – Y-Clave Connector with In…	Icu Medical, Inc.	1995	1
*	K964435	Primary IV Set Summary page 1 …ntial Equivalence: K915571 – Clave Connector – ICU Medical Inc. K970855 – Clave Connector – ICU Medical, Inc. K941190 – Clave Needless Connector – ICU Medical, Inc. K964435 – Primary IV Set – ICU Medical, Inc. K042182 – Y-Clave Connector with Integrated Check Valve – ICU Medical, Inc. K041464 – Uret…	Icu Medical, Inc.	1997	Class I
*	K042182	Y Clave Connector with Integrated Check Valve, Model XI-3432 Summary page 1 …– ICU Medical Inc. K970855 – Clave Connector – ICU Medical, Inc. K941190 – Clave Needless Connector – ICU Medical, Inc. K964435 – Primary IV Set – ICU Medical, Inc. K042182 – Y-Clave Connector with Integrated Check Valve – ICU Medical, Inc. *K041464 – Urethral Catheter and Urine Catheter Kit – Busse H…	Icu Medical, Inc.	2004	—
*	K041464	Busse Hospital Disposables Urethral Catheter Summary page 1 …Clave Needless Connector – ICU Medical, Inc. K964435 – Primary IV Set – ICU Medical, Inc. K042182 – Y-Clave Connector with Integrated Check Valve – ICU Medical, Inc. *K041464 – Urethral Catheter and Urine Catheter Kit – Busse Hospital Disposables Rationale for SE: The Clave is a needless adapter that…	Busse Hospital Disposables	2004	—

Also cleared against K915571: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K964435Primary IV SetIcu Medical, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls

What does this lineage say?

4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
6 other devices also cite its predicate K915571.

How does its category compare?

All EZD devices

EZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EZD

11so far in 2026, the most since 2007

2007high 11 (2026) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZD

130in 2025

2007high 288 (2022) · low 83 (2016)2026

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

Recalls per year · EZD

1in 2014

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EZD

288in 2025

2007high 994 (2021) · low 0 (2007)2025

MAUDE reports naming product code EZD, 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	4	121	0	0
2008	1	—	0	0
2009	2	—	0	4
2010	2	—	0	6
2011	4	116	1	4
2012	2	—	1	2
2013	4	110	0	18
2014	5	91	1	17
2015	1	—	0	21
2016	3	83	0	21
2017	2	—	0	120
2018	3	122	0	390
2019	0	—	0	466
2020	1	—	0	563
2021	0	—	0	994
2022	10	288	0	487
2023	6	214	0	553
2024	5	147	0	116
2025	6	130	0	288
2026	11	146	0	—

What is it indicated for?

ICU Medical Graduated Adapter with Clave® is indicated as an accessory to a urinary catheter which facilitates the transfer of fluids into or out of the bladder via connection to the graduated adapter. This device for single procedure use only. Connection to catheter not to exceed 30 days.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080007: Graduated Adapter with Clave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080007

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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