510(k) · Cleared
ClearedPrismacomfort, Model Autocontrol 3XPT with Autoline XPT 4R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barkey GmbH & Co. KG · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Oct 18, 2007 as substantially equivalent to K020103 (Stihler Electronic GmbH, 2002) after a 99-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 99 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020103 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020103 PrismafloStihler Electronic GmbH · 2002
- This deviceK071909 Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4RBarkey GmbH & Co. KG · 2007
- Descendant · cites it directly · 0 of its ownK082758 Prismaflo IIStihler Electronic GmbH · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK082765 Astoflo PlusStihler Electronic GmbH · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020103 | Prismaflo | Stihler Electronic GmbH | 2002 | — |
| 0 (this device) | K071909 | Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4R | Barkey GmbH & Co. KG | 2007 | — |
| +1 | K082758 | Prismaflo II | Stihler Electronic GmbH | 2008 | 3 |
| +1 | K082765 | Astoflo Plus | Stihler Electronic GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020103 | PrismafloSummary page 1…2 Identification of legally marketed predicate device to which substantial equivalence is claimed: Stihler prismaflo 510(k) Number: K020103 Stihler Electronic GmbH Julius-Hoelder-Strasse 36… | 2002 |
What descends from it? (2)
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 KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071909: Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071909
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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