510(k) · Cleared
ClearedPC-204 Tunnelor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medigroup · FKX System, Peritoneal, Automatic Delivery
Cleared on Jan 26, 1983 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 26, 1983
- Review
- 79 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK823331 PC-204 TunnelorMedigroup · 1983
- Descendant · cites it directly · 2 of its ownK071167 Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories…Medigroup, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK060897 Embedding Tool, Model TE-1000Medigroup, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK213602 Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal…Covidien, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK180485 Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal…Covidien, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560Medigroup, Inc. · 2007 · cites it directly2descendants
- K060897Embedding Tool, Model TE-1000Medigroup, Inc. · 2006 · cites it directly1descendant
- K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…Covidien, LLC · 2022 · 2 generations on0descendants
- K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…Covidien, LLC · 2018 · 2 generations on0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K823331 | PC-204 Tunnelor | Medigroup | 1983 | — |
| +1 | K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 | Medigroup, Inc. | 2007 | — |
| +1 | K060897 | Embedding Tool, Model TE-1000 | Medigroup, Inc. | 2006 | — |
| +2 | K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis… | Covidien, LLC | 2022 | — |
| +2 | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal… | Covidien, LLC | 2018 | — |
| +2 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 FKX? 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 FKX device
- #1 K243371 Byonyks X-1 APD Cycler; Byonyks Automated PD…score 11.1 · 7 generations · 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? (6)
3 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?
- Of its descendants, K071167 (Medigroup, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FKX
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FKX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKX
3,128in 2025
MAUDE reports naming product code FKX, 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 | — | 2 | 147 |
| 2008 | 0 | — | 0 | 702 |
| 2009 | 0 | — | 0 | 340 |
| 2010 | 0 | — | 5 | 4,966 |
| 2011 | 2 | — | 2 | 11,304 |
| 2012 | 0 | — | 2 | 18,034 |
| 2013 | 2 | — | 1 | 22,093 |
| 2014 | 1 | — | 4 | 28,289 |
| 2015 | 1 | — | 2 | 24,663 |
| 2016 | 0 | — | 1 | 6,137 |
| 2017 | 1 | — | 0 | 3,127 |
| 2018 | 2 | — | 3 | 5,927 |
| 2019 | 0 | — | 0 | 5,972 |
| 2020 | 1 | — | 1 | 4,598 |
| 2021 | 0 | — | 0 | 5,076 |
| 2022 | 4 | 209 | 0 | 4,503 |
| 2023 | 0 | — | 2 | 3,913 |
| 2024 | 0 | — | 0 | 3,771 |
| 2025 | 2 | — | 1 | 3,128 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K823331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K823331: PC-204 Tunnelor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823331
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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