Heart Sync, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Heart Sync, Inc.” (first 2012, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 166 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 166 |
| 2013 | 2 | 154 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 3 | 3 |
Review panels
- Cardiovascular (3)
Most recent Heart Sync, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131550 | HEART SYNC | MKJ | 2013-12-06 | 191 |
| K131494 | HEART SYNC | MKJ | 2013-09-16 | 116 |
| K120536 | HEART SYNC PEDIATRIC PHYSIO AED PAD | MKJ | 2012-08-06 | 166 |
Recalls
11 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2014-11-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- The Heart Valve Div. Medtronic Cardiovascular Surg (5 510(k)s)
- Heart Technology, Inc. (4 510(k)s)
- Heart Technology Mfg., Inc. (3 510(k)s)
- Heart Imaging Technologies, LLC (2 510(k)s)
- Heart Sync, LLC (2 510(k)s)
- Heart Alert, Inc. (1 510(k)s)
- Heart Check Systems, Inc. (1 510(k)s)
- Heart Rate, Inc. (1 510(k)s)
- Heart Rhythm Technologies, Inc. (1 510(k)s)
- Heart Sounds, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heart Sync, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Heart Sync, Inc.” (first 2012, latest 2013), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heart Sync, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heart Sync, Inc. is 166 days.
Which FDA product codes appear under Heart Sync, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 3).
Next steps
- See all 3 Heart Sync, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Heart Sync, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.