510(k) · Cleared
Recalled · Class II · 2018Prismaflo II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stihler Electronic GmbH · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Dec 19, 2008 as substantially equivalent to K020103 (Stihler Electronic GmbH, 2002) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 2002. It has been recalled 3 times.
- Decided
- Dec 19, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- KOC
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020103 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K020103 | PrismafloSummary page 1…fication: 2 Product Code: KOC Regulation: Gastroenterology - Urology Devices (21CFR876.5820) PREDICATE DEVICES: Stihler Electronic GmbH, Blood Warmer Model PRISMAFLO - K020103 Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort - K071909 DESCRIPTION: The PRISMAFLO II is a modified version of the PRI… | 2002 |
| * | K071909 | Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4RSummary page 1…ogy Devices (21CFR876.5820) PREDICATE DEVICES: Stihler Electronic GmbH, Blood Warmer Model PRISMAFLO - K020103 Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort - K071909 DESCRIPTION: The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat t… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2018 | Class II | Z-0759-2019 | Device Design | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
| Sep 6, 2018 | Class II | Z-0761-2019 | Device Design | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
| Sep 6, 2018 | Class II | Z-0760-2019 | Device Design | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K020103.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
For warming dialysis fluids and returning blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082758 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082758: Prismaflo II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082758
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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