510(k) · Cleared
ClearedAltra Nova 200 Hemodialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Althin Medical AB an Affiliate of Baxter Intl · MSF Hemodialyzer, Re-Use, High Flux
Cleared on Jul 23, 1998 as substantially equivalent to K926379 (Althin Medical AB an Affiliate of Baxter Intl, 1995) after a 514-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 23, 1998
- Review
- 514 days
- Class
- Class II
- Product code
- MSF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926379 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK926379 Altra Nova 200 HemodailyzerAlthin Medical AB an Affiliate of Baxter Intl · 1995
- This deviceK970681 Altra Nova 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926379 | Altra Nova 200 Hemodailyzer | Althin Medical AB an Affiliate of Baxter Intl | 1995 | — |
| 0 (this device) | K970681 | Altra Nova 200 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | 1998 | — |
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 MSF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K926379 | Altra Nova 200 HemodailyzerSummary page 1…1 CFR 876.5860) Product Code - 78 KDI Equivalent Device: Altra Nova® 200 Hemodialyzer (single use device) cleared for marketing via Premarket Notification 510(k) number K926379/B. Device Description: _ The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labe… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K926379.
How does its category compare?
All MSF devicesMSF Hemodialyzer, Re-Use, High Flux: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSF
FDA has decided no MSF device since 2007.
Median 510(k) review, days · MSF
Too few MSF 510(k)s in any year since 2007 to give a median.
Recalls per year · MSF
No recall names MSF since 2007.
Adverse event reports per year · MSF
1in 2023
MAUDE reports naming product code MSF, 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 | — | 0 | 509 |
| 2008 | 0 | — | 0 | 659 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis.
Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.
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/K970681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970681: Altra Nova 200 Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970681
Report an extraction error
Are you the manufacturer?
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