510(k) · Cleared

Cleared

Carbomedics Mitral Rotator

K960923510(k) TraditionalCleared Apr 29, 199654-day reviewClass I21 CFR 870.3935

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carbomedics, Inc. · MOP Rotator, Prosthetic Heart Valve

Cleared on Apr 29, 1996 as substantially equivalent to K951368 (Carbomedics, Inc., 1995) after a 54-day review. Its family tree reaches back 1 generation to 1995.

Decided: Apr 29, 1996
Review: 54 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.

By dateBy generation

Root · 1 generation backK951368 Carbomedics Exended Mitral RotatorCarbomedics, Inc. · 1995
This deviceK960923 Carbomedics Mitral RotatorCarbomedics, Inc. · 1996

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)	K960923	Carbomedics Mitral Rotator	Carbomedics, Inc.	1996	—

FIG. 1 — Lineage of K960923, 1995–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K951368	Carbomedics Exended Mitral Rotator Our OCR of the scanned summary read “1(95136__‘_” beside “510(k)”; FDA’s K951368 is the only number that fits it and carries the summary’s name for the device.	Carbomedics, Inc.	1995	—

Also cleared against K951368: 2 other devices →

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 devices

MOP 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

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code MOP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K960923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960923: Carbomedics 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/K960923

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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