Ulti-Med Intl., Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Ulti-Med Intl., Inc.” (first 1983, latest 2011), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 3 | 3 |
| FMC | Patient Examination Glove | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FXO | Suit, Surgical | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Ulti-Med Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103011 | ULTICARE SAFETY INSULIN SYRINGE | MEG | 2011-02-02 | 113 |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | KDD | 1993-06-17 | 370 |
| K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE | FMC | 1993-06-17 | 370 |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | KDD | 1992-10-19 | 231 |
| K922828 | ULCER WOUND TRAY | KKX | 1992-09-28 | 108 |
| K914244 | STERILE CUSTOM SURGICAL KITS | KDD | 1992-02-24 | 154 |
| K914431 | ABSORBENT FIBER | NAB | 1991-12-04 | 61 |
| K912693 | POST OPERATIVE SPONGE | NAB | 1991-10-04 | 108 |
| K912692 | CONFORMING BANDAGE | NAB | 1991-10-04 | 108 |
| K904896 | EYE PAD | HMP | 1990-12-05 | 36 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ulti-Med Intl., 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 Ulti-Med Intl., Inc.?
FDA lists 21 510(k) clearances under the applicant name “Ulti-Med Intl., Inc.” (first 1983, latest 2011), across 15 product codes in 2 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 Ulti-Med Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ulti-Med Intl., Inc. is 61 days.
Which FDA product codes appear under Ulti-Med Intl., Inc.?
The most frequent FDA product codes under this applicant name are KDD (Kit, Surgical Instrument, Disposable, 3); KKX (Drape, Surgical, Antimicrobial, 3); NAB (Gauze / Sponge,Nonresorbable For External Use, 3).
Next steps
- See all 21 Ulti-Med Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDD, Ulti-Med Intl., 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.