Healthcheck Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Healthcheck Corp.” (first 1984, latest 1989), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 35 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 | 0 | — |
| 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FQZ | Thermometer, Clinical Color Change | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Cardiovascular (3)
- General Hospital (2)
- Neurology (1)
Most recent Healthcheck Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884489 | C&T PREGNANCY TEST KIT | LCX | 1989-03-08 | 133 |
| K874818 | TENSTAR | GZJ | 1988-09-28 | 309 |
| K881003 | DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 | DXN | 1988-05-18 | 70 |
| K863181 | HEALTHCHECK THERM-STRIP | FQZ | 1986-09-11 | 23 |
| K861946 | PTK PLUS. HOME PREGNANCY TEST | LCX | 1986-06-16 | 27 |
| K860287 | PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 | DXN | 1986-04-28 | 90 |
| K851379 | HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 | FLL | 1985-04-12 | 4 |
| K850070 | HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 | DXN | 1985-01-22 | 18 |
| K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT | LCX | 1984-12-10 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Healthcheck Corp..
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 Healthcheck Corp.?
FDA lists 9 510(k) clearances under the applicant name “Healthcheck Corp.” (first 1984, latest 1989), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Healthcheck Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthcheck Corp. is 35 days.
Which FDA product codes appear under Healthcheck Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 3); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 9 Healthcheck Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Healthcheck Corp.'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.