510(k) · Cleared

Recalled · Class II · 2017

Cytoguard (TM) Closed Luer Connector

K112636510(k) TraditionalCleared Nov 26, 201178-day reviewClass II21 CFR 880.5440Recalls 1

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

B.Braun Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Nov 26, 2011 as substantially equivalent to K070532 (Icu Medical, Inc., 2007) and 2 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.

Decided: Nov 26, 2011
Review: 78 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 3

Its longest line of descent runs back 2 generations to K970855 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970855 Clave ConnectorIcu Medical, Inc. · 1997 · Recalled
1 generation backK051437 CML 1000Icu Medical, Inc. · 2005
This deviceK112636 Cytoguard (TM) Closed Luer ConnectorB.Braun Medical, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970855	Clave Connector	Icu Medical, Inc.	1997	52
−1	K051437	CML 1000	Icu Medical, Inc.	2005	—
0 (this device)	K112636	Cytoguard (TM) Closed Luer Connector	B.Braun Medical, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0

FIG. 1 — Lineage of K112636, 1997–2011Source: 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 FPA? 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 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? (3)

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
*	K070532	Spiros Summary page 1 …nnector, Needle free DEVICE CLASSIFICATION: Class HI, per 21 CFR §880.5440, Product Code: FPA PREDICATE DEVICES: Spiroash, ICU Medical Inc., K070532, Class II, FPA, 880.5440, Spinning SpirosWm, LCU Medical Inc., K082806,…	Icu Medical, Inc.	2007	1
*	K082806	Spinning Spiros, Model CH-2000 Summary page 1 …e: FPA PREDICATE DEVICES: Spiroash, ICU Medical Inc., K070532, Class II, FPA, 880.5440, Spinning SpirosWm, LCU Medical Inc., K082806, Class HI, FPA, 880.5440, CML Tm, ICU Medical Inc., K05 1437, Cla…	Icu Medical, Inc.	2009	5
*	K051437	CML 1000 Summary page 1 …80.5440, Spinning SpirosWm, LCU Medical Inc., K082806, Class HI, FPA, 880.5440, CML Tm, ICU Medical Inc., K05 1437, Class HFPA, 880.5440 DESCRIPTION: Cyto~uard is a needle-free, bi-directional flow, luer connector…	Icu Medical, Inc.	2005	—

Also cleared against K070532: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 10, 2017	Class II	Z-2155-2017	Nonconforming Material/Component	B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
3 of the 4 ancestors have a recall of any class.
3 other devices also cite its predicate K070532.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The CytoGuardTM Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device used as an accessory to an IV Administration Set. It is intended for the administration of parenteral fluids, medication (including hazardous drugs), blood and blood products. With the CytoGuard attached to the standard male luer of a dosing device or container, the CytoGuard valve is in a closed position. Upon connection of its male luer fitting to the female luer fitting of a patient's administration set or catheter, the valve opens to allow medication delivery to the patient. The fluid path then closes, upon disconnect.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112636 · printed Nov 5, 2026

Cite this page

510(k) Report. “K112636: Cytoguard (TM) Closed Luer Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112636

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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