510(k) · Cleared
ClearedVari-Pass Variable Length Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · KNY Accessories, Catheter, G-U
Cleared on Feb 4, 2013 as substantially equivalent to K981611 (Circon Corp., 1998) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 4, 2013
- Review
- 118 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961904 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 2 generations backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- 1 generation backK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- This deviceK123170 Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013
- Descendant · cites it directly · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
Most influential descendants
Showing 1 of 1 · See all- K182403Peel-Away IntroducerCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −2 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| −1 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| 0 (this device) | K123170 | Vari-Pass Variable Length Access Sheath | Olympus Surgical Technologies America | 2013 | — |
| +1 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 KNY? 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 KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K981611 | Snap-N-Peel IntroducersSummary page 1…Urological catheter and accessories Predicate Device The predicate devices include: 1. Gymus ACMI Snap-N-Peelm Introducer 1K981611 2. Gymus ACMI tlropass®& K05 1593 Intended Use The Gyrus ACMI Variable Leng… | 1998 |
| * | K051593 | Uropass Ureteral Access Sheath, Model 61224Summary page 1…The predicate devices include: 1. Gymus ACMI Snap-N-Peelm Introducer 1K981611 2. Gymus ACMI tlropass®& K05 1593 Intended Use The Gyrus ACMI Variable Length Access Sheath is intended to be used to permit direct passage of… | 2005 |
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 |
|---|---|---|---|
| K182403 | Peel-Away Introducer | 2019 | 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 17 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K182403 (Cook Incorporated, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981611.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Gyrus ACMI1 Vari-PassTm Adjustable Length Access Sheath is intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g.; nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123170: Vari-Pass Variable Length Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123170
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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