510(k) · Cleared
ClearedSulzer Carbomedics Low Profile Mitral Rotator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Carbomedics, Inc. · MOP Rotator, Prosthetic Heart Valve
Cleared on Aug 4, 1998 as substantially equivalent to K951368 (Carbomedics, Inc., 1995) after a 235-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 4, 1998
- Review
- 235 days
- Class
- Class I
- Product code
- MOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951368 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951368 Carbomedics Exended Mitral RotatorCarbomedics, Inc. · 1995
- This deviceK974648 Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951368 | Carbomedics Exended Mitral Rotator | Carbomedics, Inc. | 1995 | — |
| 0 (this device) | K974648 | Sulzer Carbomedics Low Profile Mitral Rotator | Sulzer Carbomedics, Inc. | 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 MOP? 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 |
|---|---|---|---|
| * | K951368 | Carbomedics Exended Mitral RotatorSummary page 1…ice applications. The Sulzer Carbomedics Low Profile Mitral Rotator has been tested and compared to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995). The results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substantially equivalent to the S… | 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.
- 2 other devices also cite its predicate K951368.
How does its category compare?
All MOP devicesMOP Rotator, Prosthetic Heart Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOP
FDA has decided no MOP device since 2007.
Median 510(k) review, days · MOP
Too few MOP 510(k)s in any year since 2007 to give a median.
Recalls per year · MOP
No recall names MOP since 2007.
Adverse event reports per year · MOP
1in 2014
MAUDE reports naming product code MOP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.
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/K974648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974648: Sulzer Carbomedics Low Profile Mitral Rotator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974648
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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