510(k) · Cleared

Recalled · Class II · 2025

Stopcocks

K760383510(k) TraditionalCleared Nov 2, 197689-day reviewClass I21 CFR 878.4200Recalls 6

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

B. Braun Instruments · KGZ Accessories, Catheter

Cleared on Nov 2, 1976 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.

Decided: Nov 2, 1976
Review: 89 days
Class: Class I
Product code: KGZ
Recalls: 6
Predicates: 0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K760383Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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
Oct 29, 2025	Class II	Z-0680-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0681-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0679-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Jan 8, 2014	Class II	Z-0987-2014	Process control	Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.
Mar 27, 2009	Not classified	Z-1432-2009	Mixed-up of materials/components	Device defect is occlusion/no flow.
Apr 14, 2003	Not classified	Z-0933-03	Other	possible leakage

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KGZ devices

KGZ Accessories, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGZ

FDA has decided no KGZ device since 2007.

Median 510(k) review, days · KGZ

Too few KGZ 510(k)s in any year since 2007 to give a median.

Recalls per year · KGZ

3in 2025

2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KGZ

30in 2025

2007high 113 (2020) · low 1 (2007)2025

MAUDE reports naming product code KGZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	3
2009	—	4	7
2010	—	2	37
2011	—	0	36
2012	—	0	17
2013	—	0	16
2014	—	0	6
2015	—	0	20
2016	—	0	54
2017	—	0	78
2018	—	0	100
2019	—	0	66
2020	—	1	113
2021	—	0	36
2022	—	0	88
2023	—	0	55
2024	—	0	44
2025	—	3	30
2026	—	0	—

https://510kreport.com/device/K760383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760383: Stopcocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760383

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026