Ultramed, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ultramed, Inc.” (first 1985, latest 1988), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 2 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (2)
- Ophthalmic (2)
- Radiology (1)
Most recent Ultramed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882015 | TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM | IYN | 1988-09-08 | 118 |
| K873989 | DOPPLEX ULTRASONIC DOPPLER SYSTEM | JOP | 1988-03-02 | 154 |
| K861378 | ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST | JOP | 1986-07-07 | 84 |
| K862021 | PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM | HQC | 1986-06-23 | 26 |
| K850578 | PHACOEMULSIFICATION TIP | HQC | 1985-04-03 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Ultramed, Inc..
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 Ultramed, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ultramed, Inc.” (first 1985, latest 1988), 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 Ultramed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultramed, Inc. is 84 days.
Which FDA product codes appear under Ultramed, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 2); JOP (Transducer, Ultrasonic, 2); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1).
Next steps
- See all 5 Ultramed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Ultramed, 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.