510(k) · Cleared
ClearedYomura Safety I.V. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yomura Technologies, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 8, 2012 as substantially equivalent to K962226 (Johnson & Johnson Medical, Inc., 1996) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 8, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962226 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK962226 Protectiv 2000 I.V. Catheter Safety SystemJohnson & Johnson Medical, Inc. · 1996
- This deviceK112542 Yomura Safety I.V. CatheterYomura Technologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962226 | Protectiv 2000 I.V. Catheter Safety System | Johnson & Johnson Medical, Inc. | 1996 | — |
| 0 (this device) | K112542 | Yomura Safety I.V. Catheter | Yomura Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K962226 | Protectiv 2000 I.V. Catheter Safety SystemSummary page 1…FOZ 3. Predicate Device Trade Name 51()Number Decision Date PROTECTIV 2000 I.V. Catheter Safety System K962226 1Z"21996 Insyte Autoguard Catheter K000235 4N2000 4. Device Descri… | 1996 |
| * | K000235 | Insyte Catheter, Insyte Autoguard CatheterSummary page 1…Number Decision Date PROTECTIV 2000 I.V. Catheter Safety System K962226 1Z"21996 Insyte Autoguard Catheter K000235 4N2000 4. Device Description The Yomura Safety I.V. Catheter consists of a catheter connected to a standard coni… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112542: Yomura Safety I.V. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112542
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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