510(k) · Cleared
ClearedReprocessed Heart Stabilizers and Positioners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NQG Stabilizer, Heart, Non-Compression, Reprocessed
Cleared on Mar 15, 2007 as substantially equivalent to K964445 (Dlp, Inc., 1997) after a 79-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 15, 2007
- Review
- 79 days
- Class
- Class I
- Product code
- NQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964445 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964445 Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
- This deviceK063844 Reprocessed Heart Stabilizers and PositionersSterilmed, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997 | — |
| 0 (this device) | K063844 | Reprocessed Heart Stabilizers and Positioners | Sterilmed, Inc. | 2007 | — |
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 NQG? 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 |
|---|---|---|---|
| * | K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Summary page 1…The reprocessed heart stabilizers and positioners are substantially equivalent to the Devices: Medtronic Octopus Tissue Stabilizer (and positioner) (K964445). The non- reprocessed heart stabilizers and positioners are Class I, 5 10(k) exempt devices. Device… | 1997 |
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.
- 3 other devices also cite its predicate K964445.
How does its category compare?
All NQG devicesNQG Stabilizer, Heart, Non-Compression, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NQG
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NQG
226in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQG
No recall names NQG since 2007.
Adverse event reports per year · NQG
2in 2018
MAUDE reports naming product code NQG, 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 | 3 | 226 | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 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?
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during off-pump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063844: Reprocessed Heart Stabilizers and Positioners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063844
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