510(k) · Cleared
ClearedUrotec/Franklin Soft Simplastic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urotec Systems Corp. · KOD Catheter, Urological
Cleared on Jul 2, 1985 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 2, 1985
- Review
- 70 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK851684 Urotec/Franklin Soft Simplastic CatheterUrotec Systems Corp. · 1985
- Descendant · cites it directly · 4 of its ownK963993 Rusch Simplastic Foley Catheterization SetRusch, Inc. · 1996
- Descendant · 2 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252537 Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
- Descendant · 2 generations on · 0 of its ownK082919 UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K963993Rusch Simplastic Foley Catheterization SetRusch, Inc. · 1996 · cites it directly4descendants
- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 2 generations on2descendants
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 3 generations on1descendant
- K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · 4 generations on0descendants
- K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851684 | Urotec/Franklin Soft Simplastic Catheter | Urotec Systems Corp. | 1985 | — |
| +1 | K963993 | Rusch Simplastic Foley Catheterization Set | Rusch, Inc. | 1996 | — |
| +2 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +3 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
| +4 | K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +2 | K082919 | UC-Care Positioning System | Uc-Care Medical Systems, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963993 | Rusch Simplastic Foley Catheterization Set | 1996 | 4 |
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?
- Of its descendants, K963993 (Rusch, Inc., 1996) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K851684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K851684: Urotec/Franklin Soft Simplastic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851684
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026