Healthteam: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Healthteam” (first 1985, latest 1989), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 200 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 | 4 | 4 |
| HGX | Pump, Breast, Powered | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
Review panels
Most recent Healthteam 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890586 | INFRARED DELUXE | ILY | 1989-08-22 | 197 |
| K890585 | INFRARED HEX | ILY | 1989-08-22 | 197 |
| K890588 | GENTLE EXPRESSIONS ELECTRIC BREAST PUMP | HGX | 1989-05-16 | 99 |
| K852653 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 | DXN | 1985-12-30 | 203 |
| K852459 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175 | DXN | 1985-12-30 | 203 |
| K852458 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145 | DXN | 1985-12-30 | 203 |
| K852457 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165 | DXN | 1985-12-30 | 203 |
| K852460 | GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY | HGX | 1985-11-14 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Healthteam.
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 Healthteam?
FDA lists 8 510(k) clearances under the applicant name “Healthteam” (first 1985, latest 1989), across 3 product codes in 3 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 Healthteam?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthteam is 200 days.
Which FDA product codes appear under Healthteam?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); HGX (Pump, Breast, Powered, 2); ILY (Lamp, Infrared, Therapeutic Heating, 2).
Next steps
- See all 8 Healthteam clearances with predicates and recalls
- Run predicate analysis for product code DXN, Healthteam'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.