510(k) · Cleared
ClearedLabel CHG for Erika Model 9608 Arterial Blood Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Medical Care, Medical Products Div., Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Sep 14, 1988 after a 587-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Sep 14, 1988
- Review
- 587 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK870722 Label CHG for Erika Model 9608 Arterial Blood LineNational Medical Care, Medical Products Div., Inc. · 1988
- Descendant · cites it directly · 12 of its ownK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002 · Recalled
- Descendant · 2 generations on · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd. · 2002 · cites it directly12descendants
- K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · 2 generations on5descendants
- K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · 2 generations on5descendants
- K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 3 generations on3descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870722 | Label CHG for Erika Model 9608 Arterial Blood Line | National Medical Care, Medical Products Div., Inc. | 1988 | — |
| +1 | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment… | Aksys, Ltd. | 2002 | 1 |
| +2 | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | Nephros, Inc. | 2012 | — |
| +2 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| +3 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | — |
| +2 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 FJK? 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 FJK device
- #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 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? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard… | 2002 | 12 |
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, K010131 (Aksys, Ltd., 2002) has gone furthest, with 12 descendants of its own.
How does its category compare?
All FJK devicesFJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FJK
255in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJK
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FJK
1,487in 2025
MAUDE reports naming product code FJK, 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 | 4 | 116 | 2 | 135 |
| 2008 | 1 | — | 2 | 86 |
| 2009 | 1 | — | 0 | 76 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 243 |
| 2012 | 2 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 114 |
| 2014 | 1 | — | 0 | 116 |
| 2015 | 0 | — | 1 | 126 |
| 2016 | 1 | — | 0 | 139 |
| 2017 | 1 | — | 0 | 131 |
| 2018 | 1 | — | 0 | 119 |
| 2019 | 0 | — | 0 | 185 |
| 2020 | 0 | — | 1 | 190 |
| 2021 | 3 | 255 | 0 | 188 |
| 2022 | 0 | — | 0 | 362 |
| 2023 | 1 | — | 0 | 585 |
| 2024 | 1 | — | 0 | 417 |
| 2025 | 1 | — | 1 (1) | 1,487 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K870722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K870722: Label CHG for Erika Model 9608 Arterial Blood Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870722
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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