510(k) · Cleared
ClearedUmbilical Vessels Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haolang Medical USA Corporation · FOS Catheter, Umbilical Artery
Cleared on May 6, 2021 as substantially equivalent to K130725 (Covidien Lp, Formerly Registered AS Kendall, 2013) after a 318-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- May 6, 2021
- Review
- 318 days
- Class
- Class II
- Product code
- FOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850884 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK850884 Argyle Polyurethane Umbilical Vessel CatheterSherwood Medical Co. · 1985
- 1 generation backK130725 Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR…Covidien Lp, Formerly Registered AS Kendall · 2013 · Recalled
- This deviceK201697 Umbilical Vessels CatheterHaolang Medical USA Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850884 | Argyle Polyurethane Umbilical Vessel Catheter | Sherwood Medical Co. | 1985 | — |
| −1 | K130725 | Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR. | Covidien Lp, Formerly Registered AS Kendall | 2013 | 3 |
| 0 (this device) | K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | 2021 | — |
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 FOS? 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
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 |
|---|---|---|---|
| * | K130725 | Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.Summary page 4…FOS Regulation No. 880.5200 3. Legally Marketed Predicate Device Trade Name Umbilical Vessels Catheter 510(k) Number K130725 Product Code FOS Manufacturer Covidien Page 1 of 7 =… | 2013 |
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 27.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All FOS devicesFOS Catheter, Umbilical Artery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FOS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FOS
Too few FOS 510(k)s in any year since 2007 to give a median.
Recalls per year · FOS
No recall names FOS since 2007.
Adverse event reports per year · FOS
56in 2025
MAUDE reports naming product code FOS, 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 | 0 | — | 0 | 26 |
| 2008 | 2 | — | 0 | 42 |
| 2009 | 2 | — | 0 | 40 |
| 2010 | 0 | — | 0 | 94 |
| 2011 | 0 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 1 | — | 0 | 95 |
| 2014 | 0 | — | 0 | 69 |
| 2015 | 0 | — | 0 | 81 |
| 2016 | 0 | — | 0 | 115 |
| 2017 | 0 | — | 0 | 139 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 64 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 1 | — | 0 | 49 |
| 2022 | 0 | — | 0 | 38 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 52 |
| 2025 | 0 | — | 0 | 56 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
---sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
---infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201697 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201697: Umbilical Vessels Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201697
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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