Heartsine Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Heartsine Technologies, Inc.” (first 2003, latest 2015), plus 1 PMA decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 136 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 | 0 | — |
| 2013 | 1 | 206 |
| 2014 | 0 | — |
| 2015 | 1 | 186 |
| 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) | 7 | 6 |
Review panels
- Cardiovascular (7)
Most recent Heartsine Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142709 | samaritan PAD 450P | MKJ | 2015-03-27 | 186 |
| K123881 | HEARTSINE SAMARITAN PAD 350P | MKJ | 2013-07-11 | 206 |
| K052465 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 | MKJ | 2006-12-12 | 460 |
| K042088 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 | MKJ | 2004-09-02 | 30 |
| K041067 | HEARTSINE SAMARITAN PAD | MKJ | 2004-05-25 | 32 |
| K023854 | SAMARITAN AED, MODEL SAM-01 | MKJ | 2003-02-14 | 87 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160008 | PMA | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) | 2017-01-12 |
Recalls
10 product recalls in 10 recall events; 8 initiated in the last five years. Most recent: 2026-07-27.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Heartsine Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Heartsine Technologies, Inc.” (first 2003, latest 2015), plus 1 PMA decision, 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 Heartsine Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heartsine Technologies, Inc. is 136 days.
Which FDA product codes appear under Heartsine Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 7).
Next steps
- See all 6 Heartsine Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Heartsine Technologies, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.