Ultimed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ultimed, Inc.” (first 2000, latest 2010), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| MMK | Container, Sharps | 2 | 2 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Ultimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100812 | ULTICARE DISPOSABLE PEN NEEDLES | FMI | 2010-06-03 | 72 |
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | MEG | 2008-06-25 | 114 |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | MMK | 2008-06-03 | 11 |
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | FMF | 2006-11-29 | 79 |
| K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 | FMI | 2005-05-11 | 77 |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | FMF | 2003-12-30 | 25 |
| K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | MMK | 2002-09-16 | 90 |
| K994230 | ULTICARE DISPOSABLE SYRINGE | FMF | 2000-03-24 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Ultimed, 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.
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.
- Ultimed Incorporated (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultimed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Ultimed, Inc.” (first 2000, latest 2010), across 4 product codes 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 Ultimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultimed, Inc. is 78 days.
Which FDA product codes appear under Ultimed, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 2); MMK (Container, Sharps, 2).
Next steps
- See all 8 Ultimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Ultimed, 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.