510(k) · Cleared
ClearedOrchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Jul 9, 2013 as substantially equivalent to K923607 (Terumo Medical Corp., 1992) after an 83-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jul 9, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923607 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK923607 Radifocus Guide Wire MTerumo Medical Corp. · 1992
- This deviceK131072 Orchestra Hydrophilic Guidewire Standard Angled, Orchestra…Coloplast A/S · 2013
- Descendant · cites it directly · 0 of its ownK150927 Orchestra Hydrophilic Guidewire standard angled, Orchestra…Coloplast A/S · 2015
Most influential descendants
Showing 1 of 1 · See all- K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire…Coloplast A/S · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923607 | Radifocus Guide Wire M | Terumo Medical Corp. | 1992 | — |
| 0 (this device) | K131072 | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic… | Coloplast A/S | 2013 | — |
| +1 | K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic… | Coloplast A/S | 2015 | — |
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 OCY? 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 |
|---|---|---|---|
| * | K923607 | Radifocus Guide Wire MSummary page 2…are substantially equivalent in performance, indication, design and materials to Radifocus® Guidewire M from Terumo Medical Corp, cleared under Premarket notification # K923607. Summary and Conclusions from the Nonclinical Tests Submitted: Product performance testing comparing the subject device to the… | 1992 |
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 |
|---|---|---|---|
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire… | 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?
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OCY
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OCY
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCY
8in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCY
133in 2025
MAUDE reports naming product code OCY, 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 | 1 | — | 0 | 3 |
| 2008 | 3 | 55 | 0 | 7 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 60 | 0 | 32 |
| 2014 | 5 | 41 | 0 | 51 |
| 2015 | 3 | 51 | 0 | 283 |
| 2016 | 1 | — | 0 | 158 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 101 |
| 2019 | 0 | — | 8 | 103 |
| 2020 | 0 | — | 0 | 128 |
| 2021 | 0 | — | 0 | 94 |
| 2022 | 0 | — | 0 | 134 |
| 2023 | 0 | — | 0 | 115 |
| 2024 | 0 | — | 0 | 131 |
| 2025 | 0 | — | 0 | 133 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131072: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131072
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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