510(k) · Cleared
ClearedI.V. Catheter, Models: Type I, Type Y, Type Straight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weihai Jierui Medical Products Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 7, 2009 as substantially equivalent to K991406 (Terumo Medical Corp., 1999) after a 261-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Aug 7, 2009
- Review
- 261 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891087 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK891087 Terumo Surflo (R) I.V. CatheterTerumo Medical Corp. · 1989 · Recalled
- 1 generation backK991406 Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterTerumo Medical Corp. · 1999
- This deviceK083429 I.V. Catheter, Models: Type I, Type Y, Type StraightWeihai Jierui Medical Products Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK142797 I.V. CatheterJiangxi Sanxin Medtec Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142797I.V. CatheterJiangxi Sanxin Medtec Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891087 | Terumo Surflo (R) I.V. Catheter | Terumo Medical Corp. | 1989 | 1 |
| −1 | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter | Terumo Medical Corp. | 1999 | — |
| 0 (this device) | K083429 | I.V. Catheter, Models: Type I, Type Y, Type Straight | Weihai Jierui Medical Products Co., Ltd. | 2009 | — |
| +1 | K142797 | I.V. Catheter | Jiangxi Sanxin Medtec Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 | Decided |
|---|---|---|---|
| * | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterSummary page 2…III- 1 Premarket Notification 510(k) Submission - Chapter III510(k) Summary Report No.: A2008-030-035 5. Predicate Device Identification: K991406 Trade/Proprietary Name: TERUMO Surflo Flex I.V. Catheter Submitter Name: Terumo Medical Corporation 6. Intended Use:… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142797 | I.V. Catheter | 2015 | 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142797 (Jiangxi Sanxin Medtec Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K991406.
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. 2009, 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?
I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to
sample blood, administer fluid intravenously or through which to place
monitoring equipment such as blood pressure monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083429: I.V. Catheter, Models: Type I, Type Y, Type Straight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083429
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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