510(k) · Cleared
ClearedRusch Simplastic Foley Catheterization Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on Dec 17, 1996 as substantially equivalent to K851684 (Urotec Systems Corp., 1985) after a 74-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Dec 17, 1996
- Review
- 74 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851684 (1985). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851684 Urotec/Franklin Soft Simplastic CatheterUrotec Systems Corp. · 1985
- This deviceK963993 Rusch Simplastic Foley Catheterization SetRusch, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252537 Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
- Descendant · cites it directly · 0 of its ownK082919 UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · cites it directly2descendants
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 2 generations on1descendant
- K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · 3 generations on0descendants
- K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851684 | Urotec/Franklin Soft Simplastic Catheter | Urotec Systems Corp. | 1985 | — |
| 0 (this device) | K963993 | Rusch Simplastic Foley Catheterization Set | Rusch, Inc. | 1996 | — |
| +1 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +2 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
| +3 | K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +1 | K082919 | UC-Care Positioning System | Uc-Care Medical Systems, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 FCM? 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 FCM device
- #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 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? (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 |
|---|---|---|---|
| * | K851684 | Urotec/Franklin Soft Simplastic CatheterSummary page 2…same materials and by the same processes (including sterilization) as the Rusch Simplastic Foley Catheter (preamendment) and Urotec/Franklin Soft Simplastic Catheters (K851684), and contains the same “gel” pack as the Inmed Foley Catheterization Tray (K832363). Sterile catheters have been biocompatibili… | 1985 |
| * | — | Rusch Simplastic Foley Catheter (preamendment) Named without a submission number | |
| † | K832363 | Foley Catheterization Tray-Various | 1984 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K162989 (Teleflexmedical, Inc., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FCM devicesFCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCM
Too few FCM 510(k)s in any year since 2007 to give a median.
Recalls per year · FCM
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCM
35in 2025
MAUDE reports naming product code FCM, 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 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 31 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 61 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 85 |
| 2022 | 0 | — | 6 | 59 |
| 2023 | 1 | — | 1 (1) | 48 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Riasch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.
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/K963993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963993: Rusch Simplastic Foley Catheterization Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963993
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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