510(k) · Cleared
ClearedSnap-N-Peel Introducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Corp. · KNY Accessories, Catheter, G-U
Cleared on Jul 30, 1998 as substantially equivalent to K961904 (Cook Urological, Inc., 1996) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Jul 30, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961904 (1996). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- This deviceK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- Descendant · cites it directly · 5 of its ownK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- Descendant · 3 generations on · 1 of its ownK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014
- Descendant · cites it directly · 1 of its ownK123170 Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013
- Descendant · 2 generations on · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · cites it directly5descendants
- K120160Rocamed Rocaus PlatinumPromepla Sam · 2012 · 2 generations on2descendants
- K140441BI-Flex Ureteral Access SheathPromepla Sam · 2014 · 3 generations on1descendant
- K123170Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013 · cites it directly1descendant
- K182403Peel-Away IntroducerCook Incorporated · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| 0 (this device) | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| +1 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| +2 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| +3 | K140441 | BI-Flex Ureteral Access Sheath | Promepla Sam | 2014 | — |
| +1 | K123170 | Vari-Pass Variable Length Access Sheath | Olympus Surgical Technologies America | 2013 | — |
| +2 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961904 | AQ Hydrophilic DilatorsSummary page 1…TEK Snap-N-Peel™ Introducer is substantially equivalent to the Cook Pecl-Away® Introducer that was approved b“-yh FDA for marketing on October 18, 1996, under 510(k) No. K961904, and to Peel™ Sheath that was approved by FDA for marketing on July 23, 1997, under 510(k) No. K971165. e Microvasive® Banana… | 1996 |
| * | K971165 | Introducer Sheath and DilatorSummary page 1…ved b“-yh FDA for marketing on October 18, 1996, under 510(k) No. K961904, and to Peel™ Sheath that was approved by FDA for marketing on July 23, 1997, under 510(k) No. K971165. e Microvasive® Banana JUL 14 ’SE 510(k) PSS CIRIUN LDRFORE Lo Summary: #K981611 CIRCON SURGITEK Division of… | 1997 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CIRCON SURGITEK’s Snap-N-Peel™ Introducers are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981611: Snap-N-Peel Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981611
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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