510(k) · Cleared
ClearedThe Heart Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Garan Scientific, Inc. · NXB Dispenser, Solid Medication
Cleared on Apr 10, 1995 after a 209-day review. The FDA summary names no predicate by number.
- Decided
- Apr 10, 1995
- Review
- 209 days
- Class
- Class I
- Product code
- NXB
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 NXB? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All NXB devicesNXB Dispenser, Solid Medication: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NXB
FDA has decided no NXB device since 2007.
Median 510(k) review, days · NXB
Too few NXB 510(k)s in any year since 2007 to give a median.
Recalls per year · NXB
No recall names NXB since 2007.
Adverse event reports per year · NXB
1in 2025
MAUDE reports naming product code NXB, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HEART PROTECTOR is an effective container for carrying a small quantity of sublingual nitroglycerin tablets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K944481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944481: The Heart Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026